Chrysalis Intelligence · Product Codes · DWF

DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cardiovascular · 25 clearances · 9 unique sponsors

Device class
Class II
Regulation 870.4210
Total clearances
25
2020-03-13 → 2026-04-23
Last 12 months
7
Unique sponsors
9
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.4210
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Medtronic, Inc. 7 3 2026-04-23
Qura S.R.L 4 0 2022-08-18
Sorin Group Italia S.R.L. 4 1 2026-01-30
Edwards Lifesciences, LLC 3 0 2024-02-05
LivaNova USA, Inc. 2 1 2026-03-11
AngioDynamics, Inc. 2 1 2025-10-24
Smart Reactors 1 1 2026-02-23
Kapp Surgical Instrument, Inc. 1 0 2021-01-28
Spectrum Medical S.R.L. 1 0 2024-05-31
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
36000 CPT Medium Introduction of needle or intracatheter, vein
36160 CPT Medium Insertion of central venous catheter; peripherally inserted central catheter (PICC)
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-23 K260195 Medtronic, Inc. Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
2026-03-11 K250937 LivaNova USA, Inc. Venous Return Cannulae
2026-02-23 K260043 Smart Reactors Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
2026-02-19 K253203 Medtronic, Inc. Retrograde Coronary Sinus Perfusion Cannulae
2026-01-30 K253671 Sorin Group Italia S.R.L. Dual Stage Venous Cannulae
2026-01-20 K253998 Medtronic, Inc. Clearview Intracoronary Shunts
2025-10-24 K253106 AngioDynamics, Inc. AngioVac Cannula
2025-07-10 K250283 LivaNova USA, Inc. RAP Femoral Venous Cannulae
2025-06-27 K250610 Sorin Group Italia S.R.L. Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
2025-06-20 K251258 Medtronic, Inc. MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula
2024-05-31 K241248 Spectrum Medical S.R.L. Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
2024-02-22 K240193 Sorin Group Italia S.R.L. R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)
2024-02-05 K233895 Edwards Lifesciences EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);
2023-12-07 K231206 Medtronic, Inc. DLP Silicone Coronary Artery Ostial Cannulae
2023-05-04 K230960 Medtronic, Inc. DLP™ Silicone Coronary Artery Ostial Cannulae
2022-08-18 K221353 Qura S.R.L Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS
2022-05-20 K213540 Qura S.R.L Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
2021-11-08 K203067 Qura S.R.L Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F
2021-09-30 K212386 AngioDynamics, Inc. AngioVac F18 85
2021-07-15 K201100 Medtronic, Inc. Bio-Medicus Life Support Catheter and Introducer
2021-06-30 K203057 Qura S.R.L Quantum Perfusion Arterial Cannula Graft
2021-01-28 K200289 Kapp Surgical Instrument, Inc. Michler-Kapp Cardiovascular Vent Catheter
2020-11-17 K200612 Sorin Group Italia S.R.L. R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
2020-03-29 K200499 Edwards Lifesciences, LLC QuickDraw Venous Cannula
2020-03-13 K200358 Edwards Lifesciences, LLC Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula