Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
FDA product code DWF · 378 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.4210
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1977-03-01 – 2026-04-23
DWF
2026-04-23
DWF
2026-03-11
Venous Return Cannulae
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DWF
2026-02-23
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
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DWF
2026-02-19
Retrograde Coronary Sinus Perfusion Cannulae
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DWF
2026-01-30
Dual Stage Venous Cannulae
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DWF
2026-01-20
Clearview Intracoronary Shunts
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DWF
2025-10-24
AngioVac Cannula
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DWF
2025-07-10
RAP Femoral Venous Cannulae
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DWF
2025-06-27
Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
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DWF
2025-06-20
MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula
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DWF
2024-05-31
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
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DWF
2024-02-22
R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)
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DWF
2024-02-05
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);
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DWF
2023-12-07
DLP Silicone Coronary Artery Ostial Cannulae
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DWF
2023-05-04
DLP™ Silicone Coronary Artery Ostial Cannulae
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DWF
2022-08-18
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
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DWF
2022-05-20
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
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DWF
2021-11-08
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F
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DWF
2021-09-30
AngioVac F18 85
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DWF
2021-07-15
Bio-Medicus Life Support Catheter and Introducer
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DWF
2021-06-30
Quantum Perfusion Arterial Cannula Graft
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DWF
2021-01-28
Michler-Kapp Cardiovascular Vent Catheter
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DWF
2020-11-17
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
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DWF
2020-03-29
QuickDraw Venous Cannula
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DWF
2020-03-13
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
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DWF
2019-07-05
AngioVac C20, AngioVac C180
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DWF
2019-05-17
CardioGard Emboli Protection Cannula
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DWF
2019-04-03
Bio-Medicus Insertion Kit
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DWF
2018-11-16
PureFlex Arterial Cannulae
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DWF
2018-10-19
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port
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DWF
2018-05-25
ProtekDuo Mini Veno-Venous Cannula Set
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DWF
2018-03-22
Bio-Medicus Adult Cannulae Kit
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DWF
2018-03-22
Bio-Medicus Adult Cannulae and Introducer
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DWF
2017-10-27
Tubing Pack
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DWF
2017-08-10
Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr
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DWF
2017-06-16
Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
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DWF
2017-06-02
Tubing Pack
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DWF
2017-01-12
Ostial Sprit Cannulae
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DWF
2016-11-30
Protek Solo 24 Fr Venous Cannula Set
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DWF
2016-03-04
PROTEK Duo 31 Fr. Veno-Venous Cannula Set
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DWF
2016-01-15
Medtronic Bio-Medicus Adult Cannula Kit
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DWF
2013-10-31
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
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DWF
2013-07-10
DLP CORONARY OSTIAL PERFUSION CANNULAE
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DWF
2013-07-05
ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
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DWF
2013-05-16
ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
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DWF
2013-03-27
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF
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DWF
2013-03-22
FEMORAL ACCESS VENOUS CANNULAE
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DWF
2013-03-15
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
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DWF
2013-03-13
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA
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DWF
2013-02-22
RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA
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DWF
2012-10-19
AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
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DWF
2012-07-26
ORIGEN REINFORCED DUAL LUMEN CATHETER
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DWF
2012-07-25
DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT
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DWF
2012-06-29
ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING
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DWF
2012-06-27
EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
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DWF
2012-06-11
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA
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DWF
2012-06-06
DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
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DWF
2012-05-30
TANDEMHEART FEMORAL ARTERIAL CANNULA SET
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DWF
2012-05-25
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
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DWF
2012-05-08
VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
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DWF
2011-12-06
NOVAPORT ONE VASCULAR ACCESS CANNULA
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DWF
2011-07-19
MEDLINE VESSEL CANNULA
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DWF
2011-06-20
CENTRIMAG DRAINAGE CANNULA KIT
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DWF
2011-06-20
CENTRIMAG RETURN CANNULA KIT
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DWF
2011-02-25
HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
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DWF
2010-10-26
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
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DWF
2010-05-10
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L
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DWF
2010-01-14
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
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DWF
2009-12-18
HLM TUBING SET WITH SOFTLINE COATING
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DWF
2009-10-20
ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
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DWF
2009-10-08
EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
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DWF
2009-08-27
MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
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DWF
2009-07-02
VORTEX CANNULA
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DWF
2009-04-03
MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)
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DWF
2009-02-10
VASCUTEK CANNULA GRAFT, MODEL CGS2008S
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DWF
2009-01-23
GISH TUBING AND CONNECTORS WITH HA COATING
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DWF
2008-12-18
X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS
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DWF
2008-12-17
STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
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DWF
2008-10-06
AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR
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DWF
2008-10-03
AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
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DWF
2008-09-18
TANDEMHEART TRANSSEPTAL CANNULA- EF 72
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DWF
2008-06-17
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
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DWF
2007-08-31
JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE
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DWF
2007-03-13
TENDERFLOW PERIATRIC ARTERIAL CANNULA
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DWF
2006-11-03
TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA
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DWF
2006-08-11
JOSTRA HLM TUBING SETS WITH SAFELINE COATING
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DWF
2006-06-23
EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222
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DWF
2006-05-10
ESTECH AORTIC EASY FLOW CANNULA
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DWF
2006-01-17
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
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DWF
2005-12-16
REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
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DWF
2005-11-22
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
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DWF
2005-09-22
MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
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DWF
2005-02-18
INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
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DWF
2005-02-08
SELECT 3D ARTERIAL CANNULA
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DWF
2004-10-06
CARDEON COBRA CATHETER
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DWF
2004-08-16
MICRO PRIME
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DWF
2004-07-28
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
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DWF
2004-06-22
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
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DWF
2004-05-25
JMS BYPASS TUBE
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DWF
2004-03-19
PEDIATRIC AORTIC ROOT CANNULA
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