Chrysalis Intelligence · Sponsors · Medtronic Cryocath, LP

Medtronic Cryocath, LP

Minneapolis, MN, US · 1 510(k) clearances · 77 PMAs

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Total clearances
1
2020-11-13 → 2020-11-13
Last 12 months
0
Product codes
1
Most recent
2020-11-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DRA Catheter, Steerable Class II Cardiovascular 1 2020-11-13
Class III

PMA approvals (77)

Total PMA records
77
Originals + supplements
Distinct product codes
2
First decision
2020-01-17
Most recent
2026-08-06
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-06 P100010-S152 Stop AF First Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2026-04-23 P100010-S153 Freezor MAX 209F3,209F5 Real-Time Process OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2026-04-23 P020045-S113 Freezor 207Fl,207F3,207F5, Freezor Xtra 217Fl,217F3,217F5 Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2025-03-27 P100010-S150 ARCTIC FRONT CRYOCATHETER SYSTEM 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2025-03-27 P020045-S112 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2025-03-18 P100010-S151 ARCTIC FRONT CRYOCATHETER SYSTEM 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-11-25 P020045-S110 Nitron CryoConsole, Nitron Foot Switch Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-11-13 P100010-S149 Manual Retraction Kit Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-11-13 P020045-S111 Coaxial Umbilical Cable Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-07-03 P100010-S148 Arctic Front Advance Pro 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-06-07 P100010-S147 Arctic Front Advance and Arctic Front Advance Pro Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-03-29 P100010-S145 Arctic Front Advanced Cardiac Cryoablation Catheter, Arctic Front Advanced PRO Cardiac Cryoablation Catheter, 9F Freezor 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-03-29 P020045-S109 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-03-26 P100010-S146 Artic Front Cryocatheter System 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-03-25 P100010-S141 Arctic Front™ Cardiac Cryoablation Catheter System Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-02-01 P020045-S105 Nitron CryoConsole and Nitron Remote Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2024-01-08 P100010-S144 Arctic Front Advanced Cardiac Cryoablation Catheter, Arctic Front Advanced PRO Cardiac Cryoablation Catheter, 9F Freezor 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2024-01-08 P020045-S108 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-12-15 P020045-S107 Coaxial Umbilical Cable - single pack, Coaxial Umbilical Cable - 12 pack 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-11-29 P100010-S143 Freezer MAX 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-11-29 P020045-S106 Freezer, Freezer Xtra 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-10-06 P100010-S142 Arctic Front Advance 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-09-19 P100010-S140 Arctic Front Advance™ Cardiac Cryoablation Catheter, Arctic Front Advance Pro™ Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-08-21 P100010-S139 Arctic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance PRO Cardiac Cryoablation Catheter Real-Time Process OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-06-01 P100010-S138 Artic Front Advanced Cardiac Cryoablation Catheter, Artic Front Advanced PRO Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-05-31 P020045-S104 CryoConsole Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-05-02 P020045-S103 CryoConsole Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2023-04-27 P100010-S131 Arctic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter 135 Review Track For 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-03-06 P100010-S137 Arctic Front Advance 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-02-28 P100010-S136 Manual Retraction Kit 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-01-19 P100010-S135 9F Freezor MAX Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-01-19 P100010-S134 Arctic Front Advance® Cardiac CryoAblation Catheters 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2023-01-19 P020045-S102 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-12-07 P100010-S133 Artic Front Advance Cardiac Cryoablation Catheter, Artic Front Advance Pro Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2022-11-09 P100010-S132 Arctic Fron Advance® Cardiac CryoAblation Catheters 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2022-09-23 P100010-S130 Arctic Front Advance Pro Cardiac CryoAblation Catheters 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2022-08-24 P100010-S129 Artic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2022-08-24 P020045-S101 Freezor TM Cardiac Cryoablation Catheter 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-06-01 P100010-S128 Arctic Front Advance, Arctic Front Advance Pro 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2022-05-06 P100010-S127 Arctic Front Advance Cardiac CryoAblation Catheters 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2022-03-16 P100010-S125 Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2022-03-15 P100010-S126 Arctic Front Advance, Arctic Front Advance Pro™ Cardiac Cryoablation Catheter and Manual Retraction Kit 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2022-03-15 P020045-S100 Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Cath 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-03-07 P100010-S123 Freezor Max Cardiac Cryoablation Catheter Real-Time Process OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2022-02-18 P020045-S098 Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2022-01-20 P100010-S124 Arctic Front Advance, Arctic Front Advance Pro TM Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-12-16 P100010-S118 Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-12-14 P100010-S122 Arctic Front Advance, Arctic Front Advance Pro 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-11-17 P100010-S121 Arctic Front Advance®, Arctic Front Advance Pro® Cardiac CryoAblation Catheters 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-11-09 P100010-S120 Arctic Front Advance Cardiac Cryoablation Catheter; Arctic Front Advance Pro Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-11-05 P100010-S119 Arctic Front® Advance Cardiac Cryoablation Catheter Real-Time Process OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-10-12 P020045-S095 Freezor Cardiac Cryoablation System Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-09-10 P100010-S117 Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter and Manual Retraction Kit Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-09-10 P020045-S097 Freezor, Freezor Xtra and Freezor MAX Cardiac Cryoablation Catheter, Electrical Umbilical and Coax Umbilical cable Normal 180 Day Track No User Fee LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-08-22 P020045-S099 Freezor Xtra Cardiac Cryoablation Catheter Real-Time Process LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-08-06 P100010-S116 Arctic Front Advance Pro Cardiac Cryoablation Catheter, 23mm, US and Arctic Front Advance Pro Cardiac Cryoablation Cathe Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-06-18 P100010-S110 Arctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter Panel Track OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-06-10 P100010-S114 Arctic Front Advance and Arctic Front Advance Pro Real-Time Process OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-06-01 P020045-S096 7F Freezor Cardiac CryoablationCatheter and CCT.2 Cryoconsole System 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-05-13 P100010-S115 Arctic Front Advance Cardiac CryoAblation Catheters 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-03-17 P020045-S094 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter, 9F Freezor MAX Cardiac Cryoabla 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2021-03-03 P100010-S113 Arctic Front Advance and Arctic Front Advance Pro 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2021-02-11 P100010-S108 Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl Normal 180 Day Track No User Fee OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-12-15 P100010-S112 Arctic Front Advance and Arctic Front Advance Pro 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-12-15 P100010-S111 Artic Front Advance and Artic Front Advance Pro Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-11-09 P100010-S109 Arctic Front Advance and Arctic Front Pro Catheters Shaft Components 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-08-13 P100010-S107 Arctic Front Cryocatheter System Real-Time Process OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-06-25 P100010-S106 Artic Front Advance Pro Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-06-23 P100010-S098 Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters Panel Track OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-06-18 P100010-S105 Artic Front Advance Pro Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-05-20 P100010-S104 Arctic Front Advance Cardiac Cryoablation Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-03-05 P100010-S102 Artic Front Advance Pro Cardiac Cryoablation Catheters 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-03-02 P020045-S092 Freezor Cardiac Cryoablation Catheter Normal 180 Day Track LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-02-24 P100010-S103 Arctic Front Advance Cardiac CryoAblation Catheters 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-02-03 P100010-S101 Arctic Front Advance Cardiac CryoAblation Catheters 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
2020-02-03 P020045-S093 Freezor, Arctic Front Advance (AFA) CryoAblation Catheters 30-Day Notice LPB Cardiac Ablation Percutaneous Catheter Unknown
2020-01-17 P100010-S100 Arctic Front Advance Pro Cryoballoon Catheter 30-Day Notice OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-11-13 K202620 FlexCath Advance Steerable Sheath and Dilator DRA Class II Cardiovascular
Data source: openFDA · Generated 2026-08-18 09:10 · Last ingest 2026-08-18T13:09:43.467718 · Pipeline: Chrysalis Intelligence