ClearanceBrief
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)
Get daily alerts for DWFSample briefCSV

Top companies in DWF

DateFirm and productCodeLinked 510(k)
Sep 11, 2026Maquet Cardiopulmonary Gmbh
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Open, Classified
DWFK131666
Sep 11, 2026Maquet Cardiopulmonary Gmbh
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Open, Classified
DWFK131666
Sep 11, 2026Maquet Cardiopulmonary Gmbh
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Open, Classified
DWFK131666
Jul 27, 2026Medtronic Perfusion Systems
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Open, Classified
DWFK260195
Jul 27, 2026Medtronic 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
DWFK260195
Jul 27, 2026Medtronic 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
DWFK031037
Jul 27, 2026Medtronic 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
DWFK031037
Jul 27, 2026Medtronic 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
DWFK031037
Jul 27, 2026Medtronic 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
DWFK031037
Jul 15, 2026Medtronic Perfusion Systems
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Open, Classified
DWFK153598
Jul 15, 2026Medtronic Perfusion Systems
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Open, Classified
DWFK024069
K180456
May 20, 2026Medtronic Perfusion Systems
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Open, Classified
DWFK860149
K953945
May 20, 2026Medtronic Perfusion Systems
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Open, Classified
DWFK860149
K953945
May 20, 2026Medtronic Perfusion Systems
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
Open, Classified
DWFK860149
K953945
May 20, 2026Medtronic Perfusion Systems
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Open, Classified
DWFK860149
K953945
May 20, 2026Medtronic Perfusion Systems
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Open, Classified
DWFK860149
K953945
May 20, 2026Medtronic Perfusion Systems
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Open, Classified
DWFK860149
K953945
May 20, 2026Medtronic Perfusion Systems
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Open, Classified
DWFK860149
K953945
May 20, 2026Medtronic Perfusion Systems
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
Open, Classified
DWFK860149
May 20, 2026Medtronic Perfusion Systems
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Open, Classified
DWFK860149
K953945
Sep 3, 2025Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Open, Classified
DWFK834039
Sep 3, 2025Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Open, Classified
DWFK834039
Sep 3, 2025Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Open, Classified
DWFK834039
Mar 13, 2025Medtronic 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
DWFK100274
Jan 17, 2025Medtronic Perfusion Systems
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Open, Classified
DWFK840002
Jan 17, 2025Medtronic Perfusion Systems
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Open, Classified
DWFK031037
Jan 17, 2025Medtronic Perfusion Systems
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Open, Classified
DWFK024069
Nov 4, 2024Medtronic Perfusion Systems
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Open, Classified
DWFK790565
Sep 12, 2024Medtronic Perfusion Systems
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Open, Classified
DWFK120988
May 10, 2024Medtronic 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
DWFK022272
May 10, 2024Medtronic 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
DWFK120612
May 10, 2024Medtronic 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
DWFK182586
May 10, 2024Medtronic 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
DWFK182586
May 10, 2024Medtronic 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
DWFK810820
May 10, 2024Medtronic 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
DWFK850385
May 10, 2024Medtronic Perfusion Systems
Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
Open, Classified
DWFK810820
May 10, 2024Medtronic Perfusion Systems
Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
Open, Classified
DWFK131269
May 10, 2024Medtronic 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
DWFK840002
Mar 19, 2024Medtronic Perfusion Systems
Medtronic DLP Vessel Cannula, Model Number REF 30000
Open, Classified
DWFK810820
Oct 14, 2021Cardiac 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
DWFK160257
Oct 12, 2021Medtronic 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
DWFNone listed
Sep 13, 2021Medtronic Perfusion Systems
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Open, Classified
DWFK190557
Apr 29, 2021Medtronic Perfusion Systems
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Terminated
DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Terminated
DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Terminated
DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Terminated
DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Terminated
DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Terminated
DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Terminated
DWFK171979
Apr 29, 2021Medtronic Perfusion Systems
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
Terminated
DWFK171979

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.