Chrysalis Intelligence · Sponsors · Biosense Webster, Inc.

Biosense Webster, Inc.

Irvine, CA, US · 20 510(k) clearances · 179 PMAs · 10 recalls (1 Class I)

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Total clearances
20
2020-01-30 → 2026-02-20
Last 12 months
2
Product codes
6
Most recent
2026-02-20
Name variants in FDA filings: Biosense Webster, Inc. / Biosense Webster
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DQK Computer, Diagnostic, Programmable Class II Cardiovascular 8 2026-02-20
MTD Catheter, Intracardiac Mapping, High-Density Array Class II Cardiovascular 5 2023-07-10
OBJ Catheter, Ultrasound, Intravascular Class II Cardiovascular 3 2024-06-28
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Class II Cardiovascular 2 2022-01-26
DYB Introducer, Catheter Class II Cardiovascular 1 2023-07-10
PGW — — — 1 2020-01-30
Class III

PMA approvals (179)

Total PMA records
179
Originals + supplements
Distinct product codes
6
First decision
2020-02-26
Most recent
2026-07-01
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-01 P030031-S141 Dual Energy THERMOCOOL SMARTTOUCH SF™ System Panel Track OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2026-06-30 P240006-S016 VARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU) Normal 180 Day Track QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2026-06-30 P030031-S143 VISITAG SURPOINT™ External Processing Unit (“EPU”); CARTO 3 System Normal 180 Day Track OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2026-06-10 P030031-S144 THERMOCOOL SMARTTOUCH SF (Uni-Directional and Bi-Directional)/DUAL ENERGYTHERMOCOOL SMARTTOUCH SF CATHETERS 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2026-04-17 P210027-S016 QDOT MICRO™ System Special (Immediate Track) OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2026-02-12 P240006-S014 VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) Normal 180 Day Track No User Fee QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2026-01-02 P240006-S013 VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-12-23 P990071-S068 nGEN™ Pump Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2025-12-23 P240006-S012 TRUPULSE™ Generator Real-Time Process QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-09-15 P990071-S067 SMARTABLATE™ System Interface Cable (D-1303-02-S) 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2025-09-10 P240006-S011 VARIPULSE™ Catheter 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-08-07 P240006-S010 VARIPULSE™ Platform; VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-07-23 P240006-S009 VARIPULSE™ Platform 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-06-26 P240006-S007 VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) Special (Immediate Track) QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-06-05 P240006-S008 VARIPULSE Bi-Directional Catheter 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-05-09 P240006-S001 VARIPULSE (TM) Catheter; TRUPULSE (TM) Generator; Sterile Interface Cable; nGEN (TM) Pump Normal 180 Day Track No User Fee QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-04-16 P240006-S006 VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-04-08 P210027-S012 QDOT MICRO™ System Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2025-03-28 P990071-S066 STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2025-03-26 P240006-S004 VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) Special (Immediate Track) QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-02-26 P990071-S065 SmartAblate System Interface Cable 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2025-02-26 P950005-S088 Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2025-02-26 P240006-S002 Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-02-26 P210027-S014 TX eco EXT Cable 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2025-02-26 P030031-S138 Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2025-02-26 P010068-S074 Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2025-02-25 P990025-S074 NAVISTAR Electrophysiology Catheter 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2025-02-25 P210027-S015 QDOT MICRO System 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2025-02-25 P040036-S100 Thermocool Deflectable Diagnostic/ Ablation Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2025-02-25 P030031-S139 Navistar Thermocool Catheter; Thermocool SmartTouch Catheter; Thermocool SmartTouch SF Catheter; Thermocool SF NAV Cathe 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2025-02-25 P010068-S075 NAVISTAR DS Electrophysiology Catheter 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2025-02-18 P240006-S003 VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-02-11 P990071-S063 SMARTABLATE™ Irrigation Tubing Set Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2025-01-22 P990071-S064 nGEN™ Pump 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-11-20 P990071-S062 Theermocool SF NAV Bi-Directional Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-11-20 P990025-S073 NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2024-11-20 P210027-S013 QDOT Micro Uni-Directional Navigation Catheter, QDOT Micro Bi-Directional Navigation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-11-20 P040036-S099 Thermocool SmartTouch Bi-Directional Navigation Catheter, Thermocool SmartTouch Uni-Directional Navigation Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-11-20 P030031-S137 NAVISTAR RMT Thermocool Electrophysiology Catheter, EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, T 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2024-11-20 P010068-S073 EZ Steer NAV DS Bi-Directional Electrophysiology Catheter, NAVISTAR DS Electrophysiology Catheter 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2024-11-15 P990071-S060 Smartablate System Interface Cable Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-11-15 P990025-S072 nMARQ Catheter Interference Cable Normal 180 Day Track No User Fee DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2024-11-15 P950005-S087 nMARQ Catheter Interference Cable Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-11-15 P210027-S008 TX eco Extension Cable Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-11-15 P040036-S097 nMARQ Catheter Interference Cable Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-11-15 P030031-S135 nMARQ Catheter Interference Cable Normal 180 Day Track No User Fee OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2024-11-15 P010068-S072 nMARQ Catheter Interference Cable Normal 180 Day Track No User Fee OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2024-11-06 P240006 VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) Original QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2024-10-30 P990071-S061 nGEN™ Pump Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-07-16 P210027-S011 QDOT MICRO Uni-Directional Navigation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-05-27 P210027-S009 QDOT MICRO Navigation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-05-24 P040036-S098 THERMOCOOL SMARTTOUCH SF Catheter Special (Immediate Track) LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-05-24 P030031-S136 THERMOCOOL SMARTTOUCH Catheter Special (Immediate Track) OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2024-05-22 P210027-S005 QDOT MICRO Uni-Directional Navigation Catheter, QDOT MICRO Bi-Directional Navigation Catheter Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-03-25 P210027-S007 QDOT Micro Navigation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-03-25 P210027-S006 QDOT MICRO™ System 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-02-19 P990071-S059 SmartAblate Irrigation Tubing Set 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-02-16 P990071-S058 SmartAblate™ Irrigation Tubing Set (SAT001) 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-09-28 P040036-S096 Thermocool Smarttouch 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-09-28 P030031-S134 Thermocool Smarttouch SF 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2023-09-19 P210027-S004 QDOT MICRO™ System Special (Immediate Track) OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-08-03 P040036-S091 THERMOCOOL SMARTTOUCH® SF Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-08-03 P030031-S129 THERMOCOOL SMARTTOUCH® Normal 180 Day Track OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2023-07-20 P210027-S002 QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-07-18 P030031-S126 THERMOCOOL SMARTTOUCH® Catheter Normal 180 Day Track OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-06-12 P990071-S057 Interface Cables 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-06-12 P990025-S071 NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2023-06-12 P950005-S086 Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, Deflectable Diagnostic/Ablation Catheter, Celsius Catheter, 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-06-12 P210027-S003 QDOT MICRO Catheter, Interface Cables 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-06-12 P040036-S095 EZ Steer ThermoCool Nav Catheter, EZ Steer ThermoCool Catheter, ThermoCool SmartTouch Catheters 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-06-12 P030031-S133 ThermoCool SmartTouch Catheters, EZ Steer ThermoCool Nav Catheter, Celsius RMT ThermoCool Catheter, ThermoCool SF NAV Ca 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2023-06-12 P010068-S071 Celsius DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, EZ Steer Nav DS Catheter, Interface Cables 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2023-05-03 P040036-S094 Thermocool Smarttouch 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-05-03 P030031-S132 Thermocool Smarttouch SF 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2023-03-10 P040036-S093 Thermocool Smarttouch Bi-directional Catheter, Thermocool Smarttouch Bi-directional Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-03-10 P030031-S131 Thermocool Smarttouch SF Uni-directional Catheter, Thermocool Smarttouch SF Uni-directional Catheter 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2023-02-24 P210027-S001 QDOT MICRO™ System, nGEN™ Generator Normal 180 Day Track OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-01-24 P990071-S055 SmartAblate™ Irrigation Tubing Set Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-11-23 P210027 QDOT MICRO™ System Original OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2022-09-30 P990071-S056 Biosense Webster Cables 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-09-30 P990025-S070 NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter, 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2022-09-30 P950005-S085 Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-09-30 P040036-S090 ThermoCool SmartTouch Catheters, NaviStar ThermoCool Catheter, NaviStar RMT ThermoCool Catheter, EZ Steer ThermoCool NAV 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-09-30 P030031-S128 Celsius RMT ThermoCool Cather, Celsius ThermoCool Cather, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool NAV Catheter 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2022-09-30 P010068-S070 Celsius FLTRR, EZ Steer Nav DS Catheter 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2022-09-09 P990025-S069 NAVISTAR Normal 180 Day Track DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2022-09-09 P950005-S084 CELSIUS Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-09-09 P040036-S089 NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST) Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-09-09 P030031-S127 CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH (ST), THERMOCOOL SMAR Normal 180 Day Track OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2022-09-09 P010068-S069 8mm Dual Sensor (DS) Catheters Normal 180 Day Track OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2022-06-08 P990071-S054 SmartAblate Irrigation Tubing Set and nGEN Pump 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-03-15 P990071-S053 SmartAblate Irrigation Tubing Set 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-03-08 P990071-S051 nGEN Pump Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-03-08 P990025-S067 NAVISTAR Normal 180 Day Track DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2022-03-08 P950005-S082 CELSIUS Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-03-08 P040036-S084 NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-03-08 P030031-S122 CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTOU Normal 180 Day Track OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2022-03-08 P010068-S067 Dual Sensor (DS) Catheters Normal 180 Day Track OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2022-02-01 P040036-S087 ThermoCool SmartTouch SF Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-02-01 P030031-S125 ThermoCool SmartTouch Real-Time Process OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-12-23 P990071-S047 SmartAblate Irrigation Tubing Set Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-11-12 P030031-S110 VISITAG SURPOINT External Processing Unit (EPU) Normal 180 Day Track OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-09-23 P990071-S046 Stockert SMARTABLATE System Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-09-22 P990071-S052 Biosense Webster Cables Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-09-22 P990025-S068 Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter Normal 180 Day Track No User Fee DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2021-09-22 P990025-S065 CELSIUS and EZ STEER Real-Time Process DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2021-09-22 P950005-S083 Biosense Webster Cables, Celsius Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter,EZ Steer Catheter, EZ Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-09-22 P950005-S080 CELSIUS DS, NAVISTAR DS, EZ STEER DS and CELSIUS FLTR Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-09-22 P040036-S086 EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool C Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-09-22 P040036-S082 NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER and THERMOCOOL SMARTTOUCH Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-09-22 P030031-S124 Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath Normal 180 Day Track No User Fee OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-09-22 P030031-S120 CELSIUS THERMOCOOL, THERMOCOOL SF, THERMOCOOL SMARTTOUCH SF, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, and THERMOCOOL SM Real-Time Process OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-09-22 P010068-S068 Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT Normal 180 Day Track No User Fee OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-09-22 P010068-S065 CELSIUS, NAVISTAR and EZ STEER Real-Time Process OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-09-07 P040036-S085 THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-09-07 P030031-S123 THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter, T 30-Day Notice — — —
2021-07-09 P990071-S050 Smartablate System Interface Cables 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-07-09 P990025-S066 Interface CABLES, Navistar Electrophysiology Catheter, EZ Steer Nav Bi-Directional Electrophysiology Catheter, Navistar 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2021-07-09 P950005-S081 Celsius FLTR (Flutter) Catheter, Celsius Electrophysiology Catheter, Webster Electrophysiology Catheter EZ Steer DS Bi-D 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-07-09 P040036-S083 EZ Steer ThemoCool Nav Bi-Directional Electrophysiology Catheter, Navistar ThermoCool Catheter, Navistar RMT ThermoCool, 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-07-09 P030031-S121 Celsius ThermoCool Electrophysiology Catheter, EZ Steer ThermoCool Bi-Directional Electrophysiology Catheter, EZ Steer T 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-07-09 P010068-S066 Celsius FLTR (Flutter) Catheter, EZ STEER NAV Bi-Directional and EZ STEER NAV DS Bi-Directional Diagnostic/Ablation Defl 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-05-13 P030031-S118 THERMOCOOL SMARTTOUCH SF Catheter Normal 180 Day Track No User Fee OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-04-28 P990071-S048 Biosense Webster Cables 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-04-28 P990025-S063 Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2021-04-28 P950005-S078 Biosense Webster Cables, Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-04-28 P040036-S080 EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-04-28 P030031-S116 Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-04-28 P010068-S063 Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-04-27 P990071-S049 THERMOCOOL™SMARTTOUCH, THERMOCOOL™SMARTTOUCH SF 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-04-27 P990025-S064 NAVISTAR™RMT THERMOCOOL, NAVISTAR™DS, EZ STEER™NAV DS 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2021-04-27 P950005-S079 CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOCOOL, CELSIUS 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-04-27 P040036-S081 EZ STEER™THERMOCOOL, THERMOCOOL™SF NAV, THERMOCOOL™SF 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-04-27 P030031-S117 EZ STEER™DS, EZ STEER™NAV, EZ STEER™, EZ STEER™THERMOCOOL NAV 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-04-27 P010068-S064 RMT THERMOCOOL, NAVISTAR™, NAVISTAR™RMT, NAVISTAR™THERMOCOOL 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-04-07 P990025-S062 Navistar, Navistar RMT, EZ Steer Nav Bi-directional Special (Immediate Track) DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2021-04-07 P950005-S077 Celsius, Celsius RMT, EZ Steer Bi-directional non nav Special (Immediate Track) LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-04-07 P040036-S079 Navistar Thermocool, EZ Steer Thermocool Nav Bi- Directional, Navistar RMT Thermocool, Thermocool SF Nav Bi-directional, Special (Immediate Track) LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-04-07 P030031-S115 Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non Special (Immediate Track) OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-04-07 P030031-S114 Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non Special (Immediate Track) OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-04-07 P010068-S062 Navistar DS, Celsius DS, EZ Steer DS Bi-directional non nav, EZ Steer Nav DS Bi-directional, Celsius FLTR Uni-directiona Special (Immediate Track) OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-03-26 P030031-S109 THERMOCOOL SMARTTOUCH SF Catheter Normal 180 Day Track No User Fee OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-03-02 P040036-S078 Thermocool Smarttouch 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-03-02 P030031-S113 Thermocool Smarttouch SF 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-02-02 P990025-S061 Navistar EP, EZ Steer Nav Bi-Directional 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2021-02-02 P950005-S076 Celsius, Celsius Flutter, EZ Steer 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-02-02 P040036-S077 EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, Navistar Thermocool 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-02-02 P030031-S112 Thermocool SF NAV, Celsius Thermocool, EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, and Navistar Thermocool 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-02-02 P010068-S061 Celsius Fluter, NavistarDS Diagnostic, Celsius DS, EZ Steer Nav DS 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-01-28 P040036-S070 EZ Steer ThermoCool Nav Deflectable Diagnostic/Ablation Catheter Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-01-28 P030031-S102 NaviStar THERMOCOOL Deflectable Diagnostic/Ablation Catheter Normal 180 Day Track No User Fee OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2021-01-22 P040036-S076 ThermoCool SmartTouch SF Catheters 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-01-22 P030031-S111 ThermoCool SmartTouch Catheters 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-10-01 P990071-S045 SmartAblate Irrigation Tubing Set 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-09-30 P030031-S100 THERMOCOOL SMARTTOUCH® SF Catheter Panel Track OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-09-24 P990025-S060 EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2020-09-24 P950005-S075 EZ Steer DS Bi-Directional Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiology Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-09-24 P030031-S108 EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, EZ Steer Thermocool Bi-Directional Electrophysiology 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-09-24 P010068-S060 EZ Steer NAV DS Bi-Directional Electrophysiology Catheter 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-07-17 P990071-S044 nGEN Pump Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-07-10 P040036-S075 THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH Navigation Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-07-10 P030031-S107 THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Cath 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-06-26 P040036-S074 Thermocool Smarttouch 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-06-26 P030031-S106 Thermocool Smarttouch SF 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-04-30 P040036-S073 THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter, Navigation Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-04-30 P030031-S105 THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter, SF Bi-Directional Navigation 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-04-16 P990071-S043 Biosense Webster Cables 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-04-16 P990025-S059 EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2020-04-16 P950005-S074 Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-04-16 P040036-S072 EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-04-16 P030031-S104 Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-04-16 P010068-S059 Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-03-31 P040036-S071 Thermocool Smarttouch Bi-Directional Navigation Catheter, Thermocool Smarttouch SF Uni-Directional Navigation Catheter, 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-03-31 P030031-S103 Thermocool Smarttouch Bi-Directional Navigation Catheter, Thermocool Smarttouch SF Uni-Directional Navigation Catheter, 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-02-26 P990025-S058 Navistar Electrophysiology Catheter 30-Day Notice DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular
2020-02-26 P950005-S073 Celsius Electrophysiology Catheter, Deflectable Tip Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiolog 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-02-26 P040036-S069 Thermocool Smart Touch Bi-Directional and Thermocool Smart Touch Electrophysiology 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-02-26 P030031-S101 EZ Steer Thermocool Navigation, EZ Steer Thermocool Bi-Directional Catheter, Thermocool SF Nav Bi-Directional Catheter, 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
2020-02-26 P010068-S058 Navistar DS Electrophysiology Catheter 30-Day Notice OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown
Safety

Recalls (10)

Class I (serious)
1
Risk of injury / death
Total recalls
10
Currently ongoing
5
Most recent
2025-01-05
DateSeverityStatusRecall # ProductCodeReason
2025-01-05 Class I Ongoing Z-1205-2025 VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based … — Due to an observed trend of neurovascular events
2024-02-16 Class II Ongoing Z-1290-2024 CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed… — Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
2023-02-21 Class II Ongoing Z-1320-2023 Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile — Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner …
2023-02-21 Class II Ongoing Z-1319-2023 Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile — Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner …
2022-06-29 Class II Ongoing Z-1677-2022 CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into … — Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile ba…
2021-02-26 Class II Completed Z-1287-2021 Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE… — There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or …
2021-02-26 Class II Completed Z-1286-2021 Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE … — There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or …
2021-02-26 Class II Completed Z-1285-2021 Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE … — There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or …
2020-04-22 Class II Terminated Z-2372-2020 PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Web… — Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
2020-04-22 Class II Terminated Z-2371-2020 PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster… — Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Filings

All 510(k) clearances (20)

Date K-number Device Code Class Specialty
2026-02-20 K252972 CARTO™ 3 EP Navigation System V8.4 DQK Class II Cardiovascular
2026-01-18 K254085 CARTO™ 3 EP Navigation System V9.0 with PIU Plus DQK Class II Cardiovascular
2025-08-22 K252302 CARTO™ 3 EP Navigation System V8.1 DQK Class II Cardiovascular
2024-06-28 K241540 NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter OBJ Class II Cardiovascular
2024-06-12 K240050 SOUNDSTAR™ CRYSTAL Ultrasound Catheter OBJ Class II Cardiovascular
2023-09-07 K231207 CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) DQK Class II Cardiovascular
2023-07-10 K231412 CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) DYB Class II Cardiovascular
2023-07-10 K231312 PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID MTD Class II Cardiovascular
2023-03-02 K230253 OPTRELL™ Mapping Catheter with TRUEref™ Technology MTD Class II Cardiovascular
2023-02-16 K223766 NUVISION™ NAV Ultrasound Catheter OBJ Class II Cardiovascular
2023-02-16 K223733 CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 DQK Class II Cardiovascular
2022-08-17 K221112 CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) DQK Class II Cardiovascular
2022-03-18 K211438 OPTRELL Mapping Catheter with TRUEref Technology MTD Class II Cardiovascular
2022-01-26 K211219 LASSOSTAR NAV Circular Mapping Catheter DRF Class II Cardiovascular
2021-10-29 K213264 CARTO 3 EP Navigation System Version 7.2 DQK Class II Cardiovascular
2020-11-25 K200484 CARTO® 3 EP Navigation System with Signal Processing Unit DQK Class II Cardiovascular
2020-08-06 K201750 Pentaray Nav eco High-Density Mapping Catheter MTD Class II Cardiovascular
2020-07-31 K193237 Carto Octaray Mapping Catheter with Trueref Technology MTD Class II Cardiovascular
2020-06-30 K193632 LassoStar Circular Mapping Catheter DRF Class II Cardiovascular
2020-01-30 K192397 TruDi Navigation System PGW — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence