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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS); Open, Classified |
DWF | K131666 |
| Sep 11, 2026 | Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS); Open, Classified |
DWF | K131666 |
| Sep 11, 2026 | Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS); Open, Classified |
DWF | K131666 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322 Open, Classified |
DWF | K260195 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222 Open, Classified |
DWF | K260195 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722 Open, Classified |
DWF | K031037 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622 Open, Classified |
DWF | K031037 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522 Open, Classified |
DWF | K031037 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422 Open, Classified |
DWF | K031037 |
| Jul 15, 2026 | Medtronic Perfusion Systems Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula Open, Classified |
DWF | K153598 |
| Jul 15, 2026 | Medtronic Perfusion Systems Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula Open, Classified |
DWF | K024069 K180456 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| Sep 3, 2025 | Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115 Open, Classified |
DWF | K834039 |
| Sep 3, 2025 | Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110 Open, Classified |
DWF | K834039 |
| Sep 3, 2025 | Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 Open, Classified |
DWF | K834039 |
| Mar 13, 2025 | Medtronic Perfusion Systems Aortic Root Cannula:
1. DLP Aortic Root Cannula
A. CANNULA 11012 AR FLOWGUARD 12GA, model no
11012
B. CANNULA 11014 AR FLOWGUARD 14GA, model no.
11014
2. MiAR Cannula:
A. CANNULA 11012L AR FLOWGUARD Open, Classified |
DWF | K100274 |
| Jan 17, 2025 | Medtronic Perfusion Systems Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) Open, Classified |
DWF | K840002 |
| Jan 17, 2025 | Medtronic Perfusion Systems EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) Open, Classified |
DWF | K031037 |
| Jan 17, 2025 | Medtronic Perfusion Systems DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr) Open, Classified |
DWF | K024069 |
| Nov 4, 2024 | Medtronic Perfusion Systems Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery Open, Classified |
DWF | K790565 |
| Sep 12, 2024 | Medtronic Perfusion Systems Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 Open, Classified |
DWF | K120988 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Venous Cannulae:
a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120,
b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124,
c) DLP 28 Fr. Malleable Open, Classified |
DWF | K022272 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Intracoronary Shunts:
a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100;
b) ClearView 1.25 mm Intracoronary Shunt, Model Numbers: 31125;
c) ClearView 2.00 mm Intracoronary Open, Classified |
DWF | K120612 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Cardioplegia Adapters:
a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,
b) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 250 Open, Classified |
DWF | K182586 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Aortic Root Cannulae and Cardioplegia Needles:
a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009;
b) DLP 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length Open, Classified |
DWF | K182586 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Vessel Cannulae:
a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004;
b) DLP 3 mm Vessel Cannula Blunt Tip, Model Number 30003 Open, Classified |
DWF | K810820 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Left Heart Vent Catheters:
a) DLP Intracardiac Sump 20 Fr, Model Number 12012,
b) DLP Left Heart Vent Catheter 10 Fr., Model Number 12008,
c) DLP Left Heart Vent Catheter 13 Fr., Model N Open, Classified |
DWF | K850385 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001 Open, Classified |
DWF | K810820 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 Open, Classified |
DWF | K131269 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Arterial Cannulae packaged as:
a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020;
b) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220;
c) DLP Curved Met Open, Classified |
DWF | K840002 |
| Mar 19, 2024 | Medtronic Perfusion Systems Medtronic DLP Vessel Cannula, Model Number REF 30000 Open, Classified |
DWF | K810820 |
| Oct 14, 2021 | Cardiac Assist, Inc SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass.
Including the following components:
a) 31 Fr ProtekDuo Veno-Venous Cannula Set
b) LifeSPARC Pump
c) 14Fr to 26 Fr Dil Open, Classified |
DWF | K160257 |
| Oct 12, 2021 | Medtronic Perfusion Systems Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers:
1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R);
2. CUSTOM PACK BB11C01R MIDI DEEP (Model Open, Classified |
DWF | None listed |
| Sep 13, 2021 | Medtronic Perfusion Systems Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile. Open, Classified |
DWF | K190557 |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | K171979 |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | K171979 |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | K171979 |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx. Terminated |
DWF | K171979 |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | K171979 |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | K171979 |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | K171979 |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | K171979 |
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