Panels › Cardiovascular › Product code DWF · Class 2
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation 870.4210
8510(k)s in 12 months (403 all time)
20recalls in 12 months (563 all time)
544recalls that name a 510(k)
Top companies in DWF
| Company | 510(k)s | Recalls |
|---|---|---|
| Maquet Cardiovascular | 0 | 184 |
| Terumo Cardiovascular Systems Corp. | 10 | 143 |
| Medtronic Perfusion Systems | 12 | 77 |
| Sorin Group USA, Inc. | 0 | 47 |
| Edwards Lifesciences | 19 | 21 |
| Medtronic, Inc. | 31 | 1 |
| Dlp, Inc. | 22 | 0 |
| 3M Health Care, Sarns | 21 | 0 |
| Shiley, Inc. | 21 | 0 |
| Edwards Lifesciences Research Medical | 4 | 13 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2026 | K263092 | Dual Stage Venous Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Sep 28, 2026 | K262052 | Tri Stage Venous Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Apr 23, 2026 | K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae Medtronic, Inc. | DWF |
| Mar 11, 2026 | K250937 | Venous Return Cannulae LivaNova USA, Inc. | DWF |
| Feb 23, 2026 | K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) Smart Reactors, IE | DWF |
| Feb 19, 2026 | K253203 | Retrograde Coronary Sinus Perfusion Cannulae Medtronic, Inc. | DWF |
| Jan 30, 2026 | K253671 | Dual Stage Venous Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Jan 20, 2026 | K253998 | Clearview Intracoronary Shunts Medtronic, Inc. | DWF |
| Oct 24, 2025 | K253106 | AngioVac Cannula AngioDynamics, Inc. | DWF |
| Jul 10, 2025 | K250283 | RAP Femoral Venous Cannulae LivaNova USA, Inc. | DWF |
| Jun 27, 2025 | K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) Sorin Group Italia S.R.L., IT | DWF |
| Jun 20, 2025 | K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula Medtronic, Inc. | DWF |
| May 31, 2024 | K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) Spectrum Medical S.R.L., IT | DWF |
| Feb 22, 2024 | K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) Sorin Group Italia S.R.L., IT | DWF |
| Feb 5, 2024 | K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, Edwards Lifesciences | DWF |
| Dec 7, 2023 | K231206 | DLP Silicone Coronary Artery Ostial Cannulae Medtronic, Inc. | DWF |
| May 4, 2023 | K230960 | DLP Silicone Coronary Artery Ostial Cannulae Medtronic, Inc. | DWF |
| Aug 18, 2022 | K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula Qura S.R.L, IT | DWF |
| May 20, 2022 | K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set Qura S.R.L, IT | DWF |
| Nov 8, 2021 | K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannu Qura S.R.L, IT | DWF |
| Sep 30, 2021 | K212386 | AngioVac F18 85 AngioDynamics, Inc. | DWF |
| Jul 15, 2021 | K201100 | Bio-Medicus Life Support Catheter and Introducer Medtronic, Inc. | DWF |
| Jun 30, 2021 | K203057 | Quantum Perfusion Arterial Cannula Graft Qura S.R.L, IT | DWF |
| Jan 28, 2021 | K200289 | Michler-Kapp Cardiovascular Vent Catheter Kapp Surgical Instrument, Inc. | DWF |
| Nov 17, 2020 | K200612 | R501 aortic root cannula without vent line, R502 aortic root cannula with vent line Sorin Group Italia S.R.L., IT | DWF |
| Mar 29, 2020 | K200499 | QuickDraw Venous Cannula Edwards Lifesciences, LLC | DWF |
| Mar 13, 2020 | K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Edwards Lifesciences, LLC | DWF |
| Jul 5, 2019 | K190594 | AngioVac C20, AngioVac C180 AngioDynamics, Inc. | DWF |
| May 17, 2019 | K182302 | CardioGard Emboli Protection Cannula Cardiogard Medical, Ltd., IL | DWF |
| Apr 3, 2019 | K190557 | Bio-Medicus Insertion Kit Medtronic, Inc. | DWF |
| Nov 16, 2018 | K180979 | PureFlex Arterial Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Oct 19, 2018 | K182586 | DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Car Medtronic, Inc. | DWF |
| May 25, 2018 | K181150 | ProtekDuo Mini Veno-Venous Cannula Set Cardiacassist, Inc. | DWF |
| Mar 22, 2018 | K180456 | Bio-Medicus Adult Cannulae Kit Medtronic, Inc. | DWF |
| Mar 22, 2018 | K180453 | Bio-Medicus Adult Cannulae and Introducer Medtronic, Inc. | DWF |
| Oct 27, 2017 | K171979 | Tubing Pack Medtronic, Inc. | DWF |
| Aug 10, 2017 | K170488 | Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannul Surge Cardiovascular | DWF |
| Jun 16, 2017 | K162215 | Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae Sorin Group Italia S.R.L., IT | DWF |
| Jun 2, 2017 | K171308 | Tubing Pack Medtronic, Inc. | DWF |
| Jan 12, 2017 | K162500 | Ostial Sprit Cannulae Spyder Medical | DWF |
| Nov 30, 2016 | K162214 | Protek Solo 24 Fr Venous Cannula Set Cardiacassist, Inc. | DWF |
| Mar 4, 2016 | K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set Cardiacassist, Inc. | DWF |
| Jan 15, 2016 | K153598 | Medtronic Bio-Medicus Adult Cannula Kit Medtronic, Inc. | DWF |
| Sep 18, 2015 | K152190 | Thoratec CentriMag Drainage (Venous) Cannula Kit Thoratec Corporation | DWF |
| Sep 18, 2015 | K152161 | Thoratec CentriMag Return (Arterial) Cannula Kit Thoratec Corporation | DWF |
| Jul 16, 2015 | K151523 | Uncoated Tubing and Connector Components Medtronic, Inc. | DWF |
| May 5, 2015 | K150536 | Terumo Circuit Tubing Terumo Cardiovascular Systems Corporation | DWF |
| Apr 9, 2015 | K150567 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT Medtronic, Inc. | DWF |
| Mar 25, 2015 | K143083 | Bio-Medicus Pediatric Cannula and Introducers Medtronic, Inc. | DWF |
| Mar 20, 2015 | K150422 | EOPA 3D Arterial Cannula Medtronic, Inc. | DWF |
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