Product Code: DWF FDA class 2 21 CFR 870.4210

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cardiovascular

The Vascular Catheter, Cannula, and Tubing for Cardiopulmonary Bypass is a cardiovascular device set used to establish vascular access and connect the patient to the extracorporeal bypass circuit, facilitating venous drainage and arterial return during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWF and it is regulated under 21 CFR 870.4210 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

401

FEI Numbers

104

Registration Numbers

104

Unique Applicants

120

Years Active

Basic Information

Product Code: DWF
Device Class: FDA class 2
Regulation Number: 870.4210
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 401 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260195	Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae	Apr 23, 2026	Substantially Equivalent	Medtronic, Inc.
K250937	Venous Return Cannulae	Mar 11, 2026	Substantially Equivalent	LivaNova USA, Inc.
K260043	Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)	Feb 23, 2026	Substantially Equivalent	Smart Reactors
K253203	Retrograde Coronary Sinus Perfusion Cannulae	Feb 19, 2026	Substantially Equivalent	Medtronic, Inc.
K253671	Dual Stage Venous Cannulae	Jan 30, 2026	Substantially Equivalent	Sorin Group Italia S.R.L.
K253998	Clearview Intracoronary Shunts	Jan 20, 2026	Substantially Equivalent	Medtronic, Inc.
K253106	AngioVac Cannula	Oct 24, 2025	Substantially Equivalent	AngioDynamics, Inc.
K250283	RAP Femoral Venous Cannulae	Jul 10, 2025	Substantially Equivalent	LivaNova USA, Inc.
K250610	Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)	Jun 27, 2025	Substantially Equivalent	Sorin Group Italia S.R.L.
K251258	MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula	Jun 20, 2025	Substantially Equivalent	Medtronic, Inc.
K241248	Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)	May 31, 2024	Substantially Equivalent	Spectrum Medical S.R.L.
K240193	R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)	Feb 22, 2024	Substantially Equivalent	Sorin Group Italia S.R.L.
K233895	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);	Feb 05, 2024	Substantially Equivalent	Edwards Lifesciences
K231206	DLP Silicone Coronary Artery Ostial Cannulae	Dec 07, 2023	Substantially Equivalent	Medtronic, Inc.
K230960	DLP Silicone Coronary Artery Ostial Cannulae	May 04, 2023	Substantially Equivalent	Medtronic, Inc.
K221353	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	Aug 18, 2022	Substantially Equivalent	Qura S.R.L
K213540	Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set	May 20, 2022	Substantially Equivalent	Qura S.R.L
K203067	Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F	Nov 08, 2021	Substantially Equivalent	Qura S.R.L
K212386	AngioVac F18 85	Sep 30, 2021	Substantially Equivalent	AngioDynamics, Inc.
K201100	Bio-Medicus Life Support Catheter and Introducer	Jul 15, 2021	Substantially Equivalent	Medtronic, Inc.
K203057	Quantum Perfusion Arterial Cannula Graft	Jun 30, 2021	Substantially Equivalent	Qura S.R.L
K200289	Michler-Kapp Cardiovascular Vent Catheter	Jan 28, 2021	Substantially Equivalent	Kapp Surgical Instrument, Inc.
K200612	R501 aortic root cannula without vent line, R502 aortic root cannula with vent line	Nov 17, 2020	Substantially Equivalent	Sorin Group Italia S.R.L.
K200499	QuickDraw Venous Cannula	Mar 29, 2020	Substantially Equivalent	Edwards Lifesciences, LLC
K200358	Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula	Mar 13, 2020	Substantially Equivalent	Edwards Lifesciences, LLC
K190594	AngioVac C20, AngioVac C180	Jul 05, 2019	Substantially Equivalent	AngioDynamics, Inc.
K182302	CardioGard Emboli Protection Cannula	May 17, 2019	Substantially Equivalent	Cardiogard Medical, Ltd.
K190557	Bio-Medicus Insertion Kit	Apr 03, 2019	Substantially Equivalent	Medtronic, Inc.
K180979	PureFlex Arterial Cannulae	Nov 16, 2018	Substantially Equivalent	Sorin Group Italia S.R.L.
K182586	DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port	Oct 19, 2018	Substantially Equivalent	Medtronic, Inc.
K181150	ProtekDuo Mini Veno-Venous Cannula Set	May 25, 2018	Substantially Equivalent	Cardiacassist, Inc.
K180456	Bio-Medicus Adult Cannulae Kit	Mar 22, 2018	Substantially Equivalent	Medtronic, Inc.
K180453	Bio-Medicus Adult Cannulae and Introducer	Mar 22, 2018	Substantially Equivalent	Medtronic, Inc.
K171979	Tubing Pack	Oct 27, 2017	Substantially Equivalent	Medtronic, Inc.
K170488	Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr	Aug 10, 2017	Substantially Equivalent	Surge Cardiovascular
K162215	Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae	Jun 16, 2017	Substantially Equivalent	Sorin Group Italia S.R.L.
K171308	Tubing Pack	Jun 02, 2017	Substantially Equivalent	Medtronic, Inc.
K162500	Ostial Sprit Cannulae	Jan 12, 2017	Substantially Equivalent	Spyder Medical
K162214	Protek Solo 24 Fr Venous Cannula Set	Nov 30, 2016	Substantially Equivalent	Cardiacassist, Inc.
K160257	PROTEK Duo 31 Fr. Veno-Venous Cannula Set	Mar 04, 2016	Substantially Equivalent	Cardiacassist, Inc.
K153598	Medtronic Bio-Medicus Adult Cannula Kit	Jan 15, 2016	Substantially Equivalent	Medtronic, Inc.
K152190	Thoratec CentriMag Drainage (Venous) Cannula Kit	Sep 18, 2015	Substantially Equivalent	Thoratec Corporation
K152161	Thoratec CentriMag Return (Arterial) Cannula Kit	Sep 18, 2015	Substantially Equivalent	Thoratec Corporation
K151523	Uncoated Tubing and Connector Components	Jul 16, 2015	Substantially Equivalent	Medtronic, Inc.
K150536	Terumo Circuit Tubing	May 05, 2015	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K150567	MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT	Apr 09, 2015	Substantially Equivalent	Medtronic, Inc.
K143083	Bio-Medicus Pediatric Cannula and Introducers	Mar 25, 2015	Substantially Equivalent	Medtronic, Inc.
K150422	EOPA 3D Arterial Cannula	Mar 20, 2015	Substantially Equivalent	Medtronic, Inc.
K141465	CARDIOGARD EMBOLI PROTECTION CANNULA	Jan 09, 2015	Substantially Equivalent	Cardiogard Medical, Ltd.
K143107	DLP Vein Graft Cannula	Jan 07, 2015	Substantially Equivalent	Medtronic, Inc.
K140569	ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)	Nov 19, 2014	Substantially Equivalent	Maquet Cardiopulmonary, AG
K142673	Bio-Medicus Adult Cannulae and Introducer	Nov 18, 2014	Substantially Equivalent	Medtronic, Inc.
K142593	AngioVac Cannula	Nov 12, 2014	Substantially Equivalent	AngioDynamics, Inc.
K141951	DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE	Aug 15, 2014	Substantially Equivalent	Medtronic, Inc.
K140999	TANDEMHEART VENO-VENOUS CANNULA	Aug 06, 2014	Substantially Equivalent	Cardiacassist, Inc.
K140192	CARPENTIER BI-CAVAL FEMORAL CANNULA	May 22, 2014	Substantially Equivalent	Medtronic, Inc.
K140165	MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE	May 20, 2014	Substantially Equivalent	Medtronic, Inc.
K140208	FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII	Mar 05, 2014	Substantially Equivalent	Edwards Lifesciences, LLC
K133445	ANGIOVAC CANNULA	Mar 05, 2014	Substantially Equivalent	Vortex Medical, Inc.
K132811	SARNS SOFT-FLOW EXTENDED AORTIC CANNULA	Feb 27, 2014	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K132451	SARNS SOFT-FLOW AORTIC CANNULA	Feb 18, 2014	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K133293	15 FR. TANDEMHEART ARTERIAL CANNULA	Feb 12, 2014	Substantially Equivalent	Cardiacassist, Inc.
K133151	SARNS HIGH FLOW AORTIC ARCH CANNULA	Feb 03, 2014	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K133236	TANDEMHEART FEMORAL VENOUS CANNULA SET	Jan 29, 2014	Substantially Equivalent	Cardiacassist, Inc.
K132995	DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO	Oct 31, 2013	Substantially Equivalent	Medtronic, Inc.
K131269	DLP CORONARY OSTIAL PERFUSION CANNULAE	Jul 10, 2013	Substantially Equivalent	Medtronic, Inc.
K131666	ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING	Jul 05, 2013	Substantially Equivalent	Maquet Cardiopulmonary, AG
K130639	ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER	May 16, 2013	Substantially Equivalent	Maquet Cardiopulmonary, AG
K123762	DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF	Mar 27, 2013	Substantially Equivalent	Medtronic, Inc.
K123303	FEMORAL ACCESS VENOUS CANNULAE	Mar 22, 2013	Substantially Equivalent	Edwards Lifesciences, LLC
K123298	FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING	Mar 15, 2013	Substantially Equivalent	Edwards Lifesciences, LLC
K123370	EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA	Mar 13, 2013	Substantially Equivalent	Edwards Lifesciences, LLC
K123187	RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA	Feb 22, 2013	Substantially Equivalent	Edwards Lifesciences, LLC
K122913	AFFINITY FUSION RECIRCULATION LINE MODEL RCL841	Oct 19, 2012	Substantially Equivalent	Medtronic, Inc.
K113869	ORIGEN REINFORCED DUAL LUMEN CATHETER	Jul 26, 2012	Substantially Equivalent	Origen Biomedical, Inc.
K120988	DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT	Jul 25, 2012	Substantially Equivalent	Medtronic, Inc.
K113459	ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING	Jun 29, 2012	Substantially Equivalent	Edwards Lifesciences, LLC
K120780	EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE	Jun 27, 2012	Substantially Equivalent	Edwards Lifesciences, LLC
K113411	EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA	Jun 11, 2012	Substantially Equivalent	Edwards Lifesciences, LLC
K120987	DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF	Jun 06, 2012	Substantially Equivalent	Medtronic, Inc.
K120543	TANDEMHEART FEMORAL ARTERIAL CANNULA SET	May 30, 2012	Substantially Equivalent	Cardiacassist, Inc.
K120612	MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT	May 25, 2012	Substantially Equivalent	Medtronic, Inc.
K120072	VENOUS DRAINAGE CANNULA WITH DURAFLO COATING	May 08, 2012	Substantially Equivalent	Edwards Lifesciences, LLC
K112565	NOVAPORT ONE VASCULAR ACCESS CANNULA	Dec 06, 2011	Substantially Equivalent	Novalung GmbH
K111147	MEDLINE VESSEL CANNULA	Jul 19, 2011	Substantially Equivalent	Medline Industries, Inc.
K110983	CENTRIMAG DRAINAGE CANNULA KIT	Jun 20, 2011	Substantially Equivalent	Levitronix, LLC
K110980	CENTRIMAG RETURN CANNULA KIT	Jun 20, 2011	Substantially Equivalent	Levitronix, LLC
K102532	HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING	Feb 25, 2011	Substantially Equivalent	Maquet Cardiopulmonary, AG
K102420	EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA	Oct 26, 2010	Substantially Equivalent	Edwards Lifesciences, LLC
K100274	MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L	May 10, 2010	Substantially Equivalent	Medtronic, Inc.
K093730	PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)	Jan 14, 2010	Substantially Equivalent	Edwards Lifesciences, LLC
K090533	HLM TUBING SET WITH SOFTLINE COATING	Dec 18, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K091542	ESTECH EASYFLOW CANNULA WITH GUIDEWIRE	Oct 20, 2009	Substantially Equivalent	Endoscopic Technologies, Inc. D/B/A Estech
K092509	EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE	Oct 08, 2009	Substantially Equivalent	Edwards Lifesciences, LLC
K090869	MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD	Aug 27, 2009	Substantially Equivalent	Medtronic Perfusion Systems
K091304	VORTEX CANNULA	Jul 02, 2009	Substantially Equivalent	Vortex Medical, Inc.
K090878	MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)	Apr 03, 2009	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K081560	VASCUTEK CANNULA GRAFT, MODEL CGS2008S	Feb 10, 2009	Substantially Equivalent	Vascutek, Ltd.
K081881	GISH TUBING AND CONNECTORS WITH HA COATING	Jan 23, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K083301	X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS	Dec 18, 2008	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K082344	STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)	Dec 17, 2008	Substantially Equivalent	Sorin Group Deutschland GmbH
K081820	AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR	Oct 06, 2008	Substantially Equivalent	Avalon Laboratories, LLC
K081933	AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR	Oct 03, 2008	Substantially Equivalent	Avalon Laboratories, LLC
K082425	TANDEMHEART TRANSSEPTAL CANNULA- EF 72	Sep 18, 2008	Substantially Equivalent	Cardiacassist, Inc.
K080034	THREE STAGE VENOUS RETURN CANNULA, MODEL 816460	Jun 17, 2008	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K072172	JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE	Aug 31, 2007	Substantially Equivalent	Maquet Cardiopulmonary, AG
K063618	TENDERFLOW PERIATRIC ARTERIAL CANNULA	Mar 13, 2007	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K062597	TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA	Nov 03, 2006	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K061832	JOSTRA HLM TUBING SETS WITH SAFELINE COATING	Aug 11, 2006	Substantially Equivalent	Maquet Cardiopulmonary, AG
K061254	EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222	Jun 23, 2006	Substantially Equivalent	Medtronic Perfusion Systems
K060101	ESTECH AORTIC EASY FLOW CANNULA	May 10, 2006	Substantially Equivalent	Endoscopic Technologies, Inc.
K052570	TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221	Jan 17, 2006	Substantially Equivalent	Cardiacassist, Inc.
K052081	REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA	Dec 16, 2005	Substantially Equivalent	Estech, Inc.
K052524	BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT	Nov 22, 2005	Substantially Equivalent	Medtronic Perfusion Systems
K052372	MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C	Sep 22, 2005	Substantially Equivalent	Medtronic Perfusion Systems
K042984	INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C	Feb 18, 2005	Substantially Equivalent	Intervascular
K043179	SELECT 3D ARTERIAL CANNULA	Feb 08, 2005	Substantially Equivalent	Medtronic Perfusion Systems
K042156	CARDEON COBRA CATHETER	Oct 06, 2004	Substantially Equivalent	Cardeon Corp.
K041650	MICRO PRIME	Aug 16, 2004	Substantially Equivalent	Innovx Medical, Inc.
K033463	EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE	Jul 28, 2004	Substantially Equivalent	Edwards Lifesciences, LLC
K033464	EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE	Jun 22, 2004	Substantially Equivalent	Edwards Lifesciences, LLC
K032977	JMS BYPASS TUBE	May 25, 2004	Substantially Equivalent	Jms North America Corp.
K040173	PEDIATRIC AORTIC ROOT CANNULA	Mar 19, 2004	Substantially Equivalent	Medtronic Perfusion Systems
K020983	JOSTRA SUCKERS, MODEL JS	Jan 30, 2004	Substantially Equivalent	Jostra AG
K034058	SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011	Jan 29, 2004	Substantially Equivalent	Medtronic Vascular
K033416	SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE	Nov 05, 2003	Substantially Equivalent	Medtronic Perfusion Systems
K033264	MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES	Oct 31, 2003	Substantially Equivalent	Medtronic Perfusion Systems
K032632	REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH	Oct 22, 2003	Substantially Equivalent	Estech, Inc.
K032041	DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)	Aug 27, 2003	Substantially Equivalent	LeMaitre Vascular, Inc.
K031776	MC2X MULTI-STAGE VENOUS CANNULA	Jul 25, 2003	Substantially Equivalent	Medtronic Perfusion Systems
K031827	ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX	Jul 02, 2003	Substantially Equivalent	Medtronic Perfusion Systems
K031151	TS3 TUBING SET	Jun 26, 2003	Substantially Equivalent	Global Blood Resources, LLC
K031518	EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,	May 22, 2003	Substantially Equivalent	Medtronic Vascular
K031037	EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE	May 13, 2003	Substantially Equivalent	Medtronic Perfusion Systems
K030231	CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON	Apr 18, 2003	Substantially Equivalent	Sorin Group Italia S.R.L.
K030696	RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)	Apr 11, 2003	Substantially Equivalent	Medtronic Perfusion Systems
K020784	JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS	Jan 09, 2003	Substantially Equivalent	Jostra AG
K024069	ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106	Jan 08, 2003	Substantially Equivalent	Medtronic Vascular
K022272	MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)	Jan 08, 2003	Substantially Equivalent	Medtronic Cardiac Surgical Products
K024058	MODIFICATION TO CARDEON AEGIS CATHETER	Dec 30, 2002	Substantially Equivalent	Cardeon Corp.
K023880	CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER	Dec 11, 2002	Substantially Equivalent	ETHICON, Inc.
K023251	PEDIATRIC ARTERIAL CANNULA	Dec 04, 2002	Substantially Equivalent	Polystan A/S
K023056	CIRCUIT TUBINGS WITH X-COATING	Nov 26, 2002	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K023622	STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35	Nov 21, 2002	Substantially Equivalent	Stockert Instrumente GmbH
K022280	STOCKERT CORONARY PERFUSION CANNULAE	Oct 11, 2002	Substantially Equivalent	Stockert Instrumente GmbH
K022321	STOCKERT V172-28 VENOUS FEMORAL CANNULA	Oct 09, 2002	Substantially Equivalent	Stockert Instrumente GmbH
K022022	JOSTRA VENT CATHETERS, MODELS LV & HKV	Sep 11, 2002	Substantially Equivalent	Jostra AG
K020693	AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101	Sep 05, 2002	Substantially Equivalent	Embol-X, Inc.
K022042	MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)	Sep 03, 2002	Substantially Equivalent	Cardeon Corp.
K020768	3T VESSEL CANNULAS	Aug 23, 2002	Substantially Equivalent	3t Medical Systems, LLC
K022174	MODIFICATION TO CARDEON AEGIS CATHETER	Jul 29, 2002	Substantially Equivalent	Cardeon Corp.
K013593	CARDEON AEGIS CATHETER	Jun 24, 2002	Substantially Equivalent	Cardeon Corp.
K020515	JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA	Apr 24, 2002	Substantially Equivalent	Jostra AG
K002578	AXILLARY ACCESS ARTERIAL CANNULA	Apr 11, 2002	Substantially Equivalent	Edwards Lifesciences, LLC
K014303	JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE	Mar 26, 2002	Substantially Equivalent	Jostra AG
K013944	JOSTRA DUAL STAGE VENOUS RETURN CANNULAE	Feb 11, 2002	Substantially Equivalent	Jostra AG
K013013	MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.	Dec 04, 2001	Substantially Equivalent	Medtronic Cardiac Surgical Products
K012774	JOSTRA ARTERIAL PERFUSION CANNULAE	Nov 16, 2001	Substantially Equivalent	Jostra AG
K012617	JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...	Nov 06, 2001	Substantially Equivalent	Jostra AG
K001509	STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE	Oct 26, 2001	Substantially Equivalent	Cobe Cardiovascular, Inc.
K012538	TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE	Aug 23, 2001	Substantially Equivalent	Medtronic Vascular
K010974	RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET	Jun 18, 2001	Substantially Equivalent	Sorin Group Italia S.R.L.
K010737	SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924	Apr 04, 2001	Substantially Equivalent	Medtronic Cardiac Surgical Products
K002019	RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET	Mar 30, 2001	Substantially Equivalent	Sorin Group Italia S.R.L.
K000776	MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP	Feb 07, 2001	Substantially Equivalent	Medtronic Cardiac Surgical Products
K002273	STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE	Jan 29, 2001	Substantially Equivalent	Stoeckert Instrumente
K001961	STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE	Jan 25, 2001	Substantially Equivalent	Stoeckert Instrumente
K003371	PUMP TUBING WITH X-COATING	Dec 21, 2000	Substantially Equivalent	Terumo Corp.
K002857	ELS CANNULA (KIT), MODEL M1210-88,M1510-88	Oct 05, 2000	Substantially Equivalent	Jostra AG
K002366	QUEST MPS BACK-UP SYSYEM	Sep 18, 2000	Substantially Equivalent	Quest Medical, Inc.
K000830	CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE	Sep 07, 2000	Substantially Equivalent	California Medical Laboratories, Inc.
K001565	STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB	Aug 10, 2000	Substantially Equivalent	Edwards Lifesciences, LLC
K001371	CARDEON ASCENDING BALLOON CANNULA (ABC)	Jul 07, 2000	Substantially Equivalent	Cardeon Corp.
K994209	STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP	Jun 14, 2000	Substantially Equivalent	Cobe Cardiovascular, Inc.
K992932	CIPA (ADULTS) CIPI (INFANTS)	Jun 07, 2000	Substantially Equivalent	Dmc Medical, Ltd.
K994243	DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP	May 05, 2000	Substantially Equivalent	Heartport, Inc.
K994171	MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE	Apr 27, 2000	Substantially Equivalent	Medtronic Cardiac Surgical Products
K993677	MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT	Apr 17, 2000	Substantially Equivalent	Medtronic Vascular
K000274	EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE	Feb 10, 2000	Substantially Equivalent	Medtronic Cardiac Surgical Products
K993818	ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE	Feb 08, 2000	Substantially Equivalent	California Medical Laboratories, Inc.
K991541	A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44	Dec 28, 1999	Substantially Equivalent	A-Med Systems, Inc.
K990396	T-ANASTAFLO	Oct 01, 1999	Substantially Equivalent	Edwards Lifesciences Research Medical
K991066	MADTRONIC DLP ARTERIAL CANNULAE	Sep 14, 1999	Substantially Equivalent	Medtronic Vascular
K983270	VOYAGER QUAD CANNULA	Jul 28, 1999	Substantially Equivalent	Cardiothoracic Systems, Inc.
K991170	RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014	Jul 02, 1999	Substantially Equivalent	Edwards Lifesciences Research Medical
K983791	PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA	Jun 11, 1999	Substantially Equivalent	Edwards Lifesciences Research Medical
K981995	QUICKDRAW VENOUS CANNULA	Apr 20, 1999	Substantially Equivalent	Heartport, Inc.
K990772	DIRECTFLOW ARTERIAL CANNULA	Mar 23, 1999	Substantially Equivalent	Heartport, Inc.
K974259	VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE	Dec 01, 1998	Substantially Equivalent	Edwards Lifesciences Research Medical
K981009	HEARTPORT ENDOPULMONARY VENT CATHETER	Sep 04, 1998	Substantially Equivalent	Heartport, Inc.
K981601	CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER	Jul 28, 1998	Substantially Equivalent	Sorin Group Italia S.R.L.
K974736	HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER	Jul 15, 1998	Substantially Equivalent	Heartport, Inc.
K964205	BETTER-TUBING	Apr 08, 1998	Substantially Equivalent	Circulatory Technology, Inc.
K972993	CHASE FEMORAL ACCESS CANNULATION SET	Mar 31, 1998	Substantially Equivalent	Chase Medical, Inc.
K971928	QUEST VESSEL CATHETER	Nov 06, 1997	Substantially Equivalent	Quest Medical, Inc.
K972261	RIVETTI-LEVINSON INSTRALUMINAL SHUNT	Sep 15, 1997	Substantially Equivalent	Integra Neurocare, LLC
K971023	CHASE THORACIC CATHETER	Sep 08, 1997	Substantially Equivalent	Chase Medical, Inc.
K972503	CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE	Aug 26, 1997	Substantially Equivalent	Sorin Group Italia S.R.L.
K972665	CHASE BLOOD VESSEL SHUNT	Aug 22, 1997	Substantially Equivalent	Chase Medical, Inc.
K971021	CHASE PHRENIC NERVE PAD	Aug 12, 1997	Substantially Equivalent	Chase Medical, Inc.
K971019	CHASE VESSEL CANNULA	Jul 21, 1997	Substantially Equivalent	Chase Medical, Inc.
K964374	SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT	Jun 18, 1997	Substantially Equivalent	3M Healthcare
K964373	SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT	Jun 18, 1997	Substantially Equivalent	3M Healthcare
K971291	HEARTPORT ENDOARTERIAL RETURN CANNULA	Jun 17, 1997	Substantially Equivalent	Heartport, Inc.
K971041	CHASE CORONARY OSTIAL PERFUSION CANNULA	May 13, 1997	Substantially Equivalent	Chase Medical, Inc.
K970914	CHASE AORTIC PERFUSION CANNULA	May 13, 1997	Substantially Equivalent	Chase Medical, Inc.
K964391	CHASE LEFT VENT SAFETY VALVE	May 13, 1997	Substantially Equivalent	Chase Medical, Inc.
K964393	CHASE RETROGRADE CARDIOPLEGIA CANNULA	Apr 23, 1997	Substantially Equivalent	Chase Medical, Inc.
K964200	CHASE MULTIPLE PERFUSION SET	Apr 16, 1997	Substantially Equivalent	Chase Medical, Inc.
K964194	CHASE CURVED LEFT HEART VENT CATHETER	Apr 16, 1997	Substantially Equivalent	Chase Medical, Inc.
K964193	CHASE AORTIC ARCH CANNULA	Apr 16, 1997	Substantially Equivalent	Chase Medical, Inc.
K964199	CHASE CORONARY SINUS PERFUSION CANNULA	Mar 19, 1997	Substantially Equivalent	Chase Medical, Inc.
K964198	CAHSE AORTIC ROOT CANNULA	Mar 19, 1997	Substantially Equivalent	Chase Medical, Inc.
K964195	CHASE TWO STAGE VENOUS RETURN CATHETER	Mar 19, 1997	Substantially Equivalent	Chase Medical, Inc.
K962835	HEARTPORT ENDOVENOUS DRAINAGE CANNULA	Feb 10, 1997	Substantially Equivalent	Heartport, Inc.
K964248	HEARTPORT ENDOCORONARY SINUS CATHETR	Jan 22, 1997	Substantially Equivalent	Heartport, Inc.
K961594	BETTER-VENTER	Sep 05, 1996	Substantially Equivalent	Circulatory Technology, Inc.
K961927	RMI HEMOCONCENTRACTOR TUBING SET	Aug 13, 1996	Substantially Equivalent	Research Medical, Inc.
K961717	NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS	Jul 18, 1996	Substantially Equivalent	Naltiac Medical, Inc.
K961180	NMI ANTEGRAD CARDIOPLEGIA CANNULA	Jun 21, 1996	Substantially Equivalent	Naltiac Medical, Inc.
K961270	HEARTPORT ENDOSINUS CATHETER	Jun 18, 1996	Substantially Equivalent	Heartport, Inc.
K961245	HEARTPORT ENDOPULMONARY VENT	Jun 18, 1996	Substantially Equivalent	Heartport, Inc.
K955121	HEARTPORT ENDOARTERIAL RETURN CANNUAL	May 10, 1996	Substantially Equivalent	Heartport, Inc.
K955818	FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER	Mar 26, 1996	Substantially Equivalent	Quest Medical, Inc.
K953945	RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET	Mar 26, 1996	Substantially Equivalent	Dlp, Inc.
K951088	QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS	Jun 14, 1995	Substantially Equivalent	Quest Medical, Inc.
K943934	AORTIC ARCH CANNULAS	Jun 02, 1995	Substantially Equivalent	Sorin Group Italia S.R.L.
K950814	QUEST ANTEGRADE CARDIOPLEGIA CANNULA	May 25, 1995	Substantially Equivalent	Quest Medical, Inc.
K941916	QUEST CORONARY SINUS PERFUSION CANNULA -FRCC	Apr 06, 1995	Substantially Equivalent	Quest Medical, Inc.
K941166	QUEST CORONARY SINUS PERFUSION CANNULA	Jan 17, 1995	Substantially Equivalent	Quest Medical, Inc.
K932208	EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM	Aug 09, 1994	Substantially Equivalent	Baxter Healthcare Corp
K934127	SARNS LOW JETTING AORTIC ARCH CANNULA	Feb 22, 1994	Substantially Equivalent	3M Health Care, Sarns
K925049	QUEST HEART INSULATION PAD	Feb 01, 1994	Substantially Equivalent	Quest Medical, Inc.
K931586	VITAL-PORT MINI VASCULAR ACCESS SYSTEM	Sep 27, 1993	Unknown	Med Institute, Inc.
K924529	SIGNATURE(TM) CUSTOM TUBING PACK	Jun 23, 1993	Unknown	Avecor Cardiovascular, Inc.
K925442	SARNS RETROGRADE CANNULA	May 21, 1993	Substantially Equivalent	3M Health Care, Sarns
K930684	BARD WILLIAM HARVEY TWO STAGE CANNULA	May 11, 1993	Substantially Equivalent	C.R. Bard, Inc.
K920902	MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA	May 11, 1993	Substantially Equivalent	3M Health Care, Sarns
K930620	BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA	May 07, 1993	Substantially Equivalent	C.R. Bard, Inc.
K930593	BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU	May 06, 1993	Substantially Equivalent	C.R. Bard, Inc.
K924642	MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER	Mar 26, 1993	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K923483	BARD WILLIAM HARVEY AORTIC ARCH CANULAE	Mar 22, 1993	Substantially Equivalent	C.R. Bard, Inc.
K922471	SARNS RETROGRADE CANNULA - AUTO INFLATE	Mar 12, 1993	Substantially Equivalent	3M Health Care, Sarns
K924643	MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT	Dec 08, 1992	Substantially Equivalent	Medtronic Bio-Medicus, Inc.
K922992	CONDUCER CARDIOPLEGIA SET SITH MP4	Sep 18, 1992	Substantially Equivalent	3M Health Care, Ltd.
K915268	CATHETER TWO STAGE VENOUS RETURN	Jul 27, 1992	Substantially Equivalent	Dlp, Inc.
K915193	SARNS RETROGRADE CANNULA	Mar 04, 1992	Substantially Equivalent	3M Health Care, Sarns
K910004	FURUI SHUNT, 2-WAY AND 3-WAY	Sep 19, 1991	Substantially Equivalent	Theramed, Inc.
K910021	CARDIOPULMONARY BYPASS PUMP TUBING	May 22, 1991	Substantially Equivalent	Jtl Medical Corp.
K905224	CARDIOPULMONARY BYPASS VASCULAR CATHETER	Feb 05, 1991	Substantially Equivalent	3M Health Care, Sarns
K905638	SARNS INVENT CATHETERS	Feb 01, 1991	Substantially Equivalent	3M Health Care, Sarns
K905312	DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS	Jan 15, 1991	Substantially Equivalent	Baxter Bentley Laboratories, Inc.
K902394	RESUBMITTED MULTIORGAN PERFUSION CANNULA	Sep 27, 1990	Substantially Equivalent	Fresenius USA, Inc.
K902277	BARD EXTRACORPOREAL CIRCULATION CANNULAE	Aug 14, 1990	Substantially Equivalent	C.R. Bard, Inc.
K901074	CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA	Jul 06, 1990	Substantially Equivalent	Dlp, Inc.
K901231	RMI CARDIOPLEGIA DELIVERY KITS	Jun 08, 1990	Substantially Equivalent	Research Medical, Inc.
K896338	VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA	May 17, 1990	Substantially Equivalent	Voss Medical Products
K900753	SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)	Apr 10, 1990	Substantially Equivalent	Shiley, Inc.
K897022	PICSO CANNULA, CATALOG CODE 94315	Mar 16, 1990	Substantially Equivalent	Dlp, Inc.
K896778	RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE	Feb 27, 1990	Substantially Equivalent	Research Medical, Inc.
K896777	RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE	Feb 27, 1990	Substantially Equivalent	Research Medical, Inc.
K897026	CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.	Feb 26, 1990	Substantially Equivalent	Canyon Medical Products
K896636	RMI ANTEPLEGIA CANNULA	Feb 15, 1990	Substantially Equivalent	Research Medical, Inc.
K895352	KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN	Nov 29, 1989	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K894684	PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT	Oct 17, 1989	Substantially Equivalent	Pioneering Technologies, Inc.
K891576	FEM-FLEX FEMORAL ACCESS CANNULATION SET	Oct 12, 1989	Substantially Equivalent	Research Medical, Inc.
K890980	MODIFIED STOCKERT-SHILEY VENOUS CATHETER	May 01, 1989	Substantially Equivalent	Shiley, Inc.
K890024	SARNS VENT CATHETER	Mar 02, 1989	Substantially Equivalent	3M Company
K883412	THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)	Feb 08, 1989	Substantially Equivalent	Promedica Products, Inc.
K885188	MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY	Feb 06, 1989	Substantially Equivalent	Quinton, Inc.
K884310	ANGIOPUMP TUBING SET	Jan 10, 1989	Substantially Equivalent	Olympus Corp.
K884393	MODIFIED SHILEY FEMORAL ARTERIAL CANNULA	Dec 27, 1988	Substantially Equivalent	Shiley, Inc.
K883981	GUIDING CATHETER (TIP SOFTNESS CHANGE)	Nov 03, 1988	Substantially Equivalent	Devices For Vascular Intervention, Inc.
K883221	PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT	Oct 13, 1988	Substantially Equivalent	Pioneering Technologies, Inc.
K882771	EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER	Sep 27, 1988	Substantially Equivalent	Cook, Inc.
K882034	INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER	Jul 28, 1988	Substantially Equivalent	Buckman Co., Inc.
K881733	SHILEY FEMORAL CORONARY PERFUSION CATHETER	Jul 06, 1988	Substantially Equivalent	Shiley, Inc.
K881734	SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER	Jul 05, 1988	Substantially Equivalent	Shiley, Inc.
K881691	PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA	Jul 05, 1988	Substantially Equivalent	Shiley, Inc.
K881330	COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK	Jun 10, 1988	Substantially Equivalent	Cobe Laboratories, Inc.
K881352	RIGHT ATRIAL CATHETER INSERTION TRAY	Jun 09, 1988	Substantially Equivalent	Quinton, Inc.
K881074	SHILEY FEMORAL VENOUS CANNULA	May 31, 1988	Substantially Equivalent	Shiley, Inc.
K881072	SHILEY FEMORAL ARTERIAL CANNULA	May 31, 1988	Substantially Equivalent	Shiley, Inc.
K880887	NEOCATH	May 24, 1988	Substantially Equivalent	Taris Corp.
K880777	8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM	May 24, 1988	Substantially Equivalent	Medsurg Industries, Inc.
K880779	MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY	May 09, 1988	Substantially Equivalent	Medsurg Industries, Inc.
K880421	DESCENDING ARCH CANNULA	Apr 28, 1988	Substantially Equivalent	Dlp, Inc.
K880180	STATFLO	Mar 22, 1988	Substantially Equivalent	Imodex, Inc.
K880103	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL.	Mar 22, 1988	Substantially Equivalent	Research Medical, Inc.
K875353	PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT	Mar 22, 1988	Substantially Equivalent	Dlp, Inc.
K875048	SARNS VENOATRIAL CATHETER	Feb 18, 1988	Substantially Equivalent	3M Health Care, Sarns
K874899	CANYON MEDICAL FEMORAL BYPASS CANNULAE	Feb 18, 1988	Substantially Equivalent	Canyon Medical Products
K874853	POLYSTAN TWO STAGE CATHETERS	Feb 05, 1988	Substantially Equivalent	Polystan C/O Vitalcor, Inc.
K874852	POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS	Feb 05, 1988	Substantially Equivalent	Polystan C/O Vitalcor, Inc.
K874896	SARNS VISIFLOW AORTIC ARCH CANNULA	Feb 02, 1988	Substantially Equivalent	3M Health Care, Sarns
K874834	ARGYLE CARDIOPLEGIA CANNULA	Jan 19, 1988	Substantially Equivalent	Sherwood Medical Co.
K872033	BIO-MEDICUS CANNULA-TUBING	Dec 07, 1987	Substantially Equivalent	Bio Medicus, Inc.
K873212	SARNS CARDIOPLEGIA/VENT CATHETERS	Nov 06, 1987	Substantially Equivalent	3M Health Care, Sarns
K872043	CHURCHILL INTER-CARDIAC SUCKER	Sep 30, 1987	Substantially Equivalent	Churchill Corp.
K872788	MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN	Sep 25, 1987	Substantially Equivalent	Uresil Corp.
K872762	TORAY ANTHRON AORTA BYPASS TUBES	Sep 24, 1987	Substantially Equivalent	Toray Industries (America), Inc.
K872159	DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES	Aug 12, 1987	Substantially Equivalent	Shiley, Inc.
K871844	ARGYLE VASCULAR BYPASS SET	Aug 03, 1987	Substantially Equivalent	Sherwood Medical Co.
K870819	BUBBLE TRAP CAT. NO. B-180	Jun 08, 1987	Substantially Equivalent	American Omni Medical, Inc.
K870421	TDMAC-HEPARIN COATED RMI	May 22, 1987	Substantially Equivalent	Research Medical, Inc.
K870507	GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA	Mar 16, 1987	Substantially Equivalent	Research Medical, Inc.
K870109	RMI VENOUS DRAINAGE CANNULA	Mar 16, 1987	Substantially Equivalent	Research Medical, Inc.
K865079	ASPIRATING NEEDLE, CATALOG CODE #12006	Mar 03, 1987	Substantially Equivalent	Dlp, Inc.
K863342	SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER	Mar 03, 1987	Substantially Equivalent	Angiomedics, Inc.
K863740	RMI FEMORAL VENOUS DRAINAGE CANNULA	Feb 19, 1987	Substantially Equivalent	Research Medical, Inc.
K863558	URESIL CAROTID SHUNT	Nov 24, 1986	Substantially Equivalent	Uresil Corp.
K862190	WALRUS: DOUBLE BALLOON SHUNTING CATHETER	Nov 03, 1986	Substantially Equivalent	Medical Parameters, Inc.
K862634	TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT	Oct 31, 1986	Substantially Equivalent	Research Medical, Inc.
K861790	RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT	Jul 21, 1986	Substantially Equivalent	Research Medical, Inc.
K860136	BARD-PARKER CAROTID SHUNT	Jun 25, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K861322	RMI POROUS VENT PLUG	May 30, 1986	Substantially Equivalent	Research Medical, Inc.
K861310	STOCKERT-SHILEY AORTIC ROOT CANNULAE	May 30, 1986	Substantially Equivalent	Shiley, Inc.
K861116	TORAY ANTHRON BYPASS TUBES	May 28, 1986	Substantially Equivalent	Toray Industries (America), Inc.
K861103	CHEST DRAINAGE PACK, CDP-1000	May 28, 1986	Substantially Equivalent	Gish Biomedical, Inc.
K860743	CAROTID BYPASS SHUNT WITH SAMPLING ARM	May 28, 1986	Substantially Equivalent	Clincal Instruments Corp.
K860742	CAROTID BYPASS SHUNT	May 28, 1986	Substantially Equivalent	Clincal Instruments Corp.
K860497	CAROTID BALLOON SHUNT	May 28, 1986	Substantially Equivalent	Imodex, Inc.
K861496	STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA	May 27, 1986	Substantially Equivalent	Shiley, Inc.
K861096	CARDIOPULMONARY CANNULA TUBING	May 21, 1986	Substantially Equivalent	Bio Medicus, Inc.
K860988	RMI CAROTID BY-PASS SHUNT	May 21, 1986	Substantially Equivalent	Research Medical, Inc.
K860149	VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015	Mar 31, 1986	Substantially Equivalent	Dlp, Inc.
K854640	MODIFIED CORONARY CARDIOPLEGIA ADAPTOR	Feb 10, 1986	Substantially Equivalent	Shiley, Inc.
K854487	VENOUS RETURN CANNULA W/CUFF 91039	Feb 10, 1986	Substantially Equivalent	Dlp, Inc.
K853128	SARNS EVACUPLEGE CATHETER	Oct 17, 1985	Substantially Equivalent	3M Health Care, Sarns
K852984	SHILEY CSD EXTENSION LINE WITH FILTER	Oct 11, 1985	Substantially Equivalent	Shiley, Inc.
K851323	AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU	Aug 12, 1985	Substantially Equivalent	C.R. Bard, Inc.
K833047	DOSIMETRIC RELEASE OF RAD. TUBING PAC	Jun 11, 1985	Substantially Equivalent	American Bentley
K850925	BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER	May 21, 1985	Substantially Equivalent	American Bentley
K850917	ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN	May 21, 1985	Substantially Equivalent	Sherwood Medical Co.
K850385	INTRACARDIAC SUMP 12010	Apr 29, 1985	Substantially Equivalent	Dlp, Inc.
K845046	PUL,MONARY ARTERY VENT CATHETER	Apr 03, 1985	Substantially Equivalent	Dlp, Inc.
K845045	VENOUS RETURN CATHETER SS-1	Apr 03, 1985	Substantially Equivalent	Dlp, Inc.
K850356	PRUITT-VASCULAR SHUNTS	Feb 27, 1985	Substantially Equivalent	Ideas For Medicine, Inc.
K844140	STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH	Dec 27, 1984	Substantially Equivalent	Shiley, Inc.
K844139	STOCKERT-SHILEY INTRACARDIAC SUCKERS	Dec 27, 1984	Substantially Equivalent	Shiley, Inc.
K844138	STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI	Dec 27, 1984	Substantially Equivalent	Shiley, Inc.
K844137	STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN	Dec 27, 1984	Substantially Equivalent	Shiley, Inc.
K843542	SHILEY CORONARY CARDIOPLEGIA ADAPTOR	Oct 18, 1984	Substantially Equivalent	Shiley, Inc.
K843444	ARGYLE SILICONE LEFT VENTRICULAR AND	Oct 18, 1984	Substantially Equivalent	Sherwood Medical Co.
K842889	ARGYLE CUSTOM TUBING PACK	Aug 27, 1984	Substantially Equivalent	Sherwood Medical Co.
K842375	VENOUS CANNULA W/BENT, TIP WIRE	Aug 10, 1984	Substantially Equivalent	Dlp, Inc.
K841482	PRESSURE CATHETER PLACEMENT SET 50010	Jun 11, 1984	Substantially Equivalent	Dlp, Inc.
K840914	ARGYLE TAPERED VASCULAR SHUNT	Apr 17, 1984	Substantially Equivalent	Sherwood Medical Co.
K834134	SARNS 8.0 SOFT ARC CANNULA	Apr 17, 1984	Substantially Equivalent	3M Health Care, Sarns
K833830	3-DAY BIOINDICATOR RELEASE PROCESS FOR	Apr 12, 1984	Substantially Equivalent	Shiley, Inc.
K840002	ARTERIAL CANNULA CURVED BEVELED TIP	Feb 13, 1984	Substantially Equivalent	Dlp, Inc.
K840001	ARTERIAL CANNULA STRAIGHT BEVELED TIP	Feb 13, 1984	Substantially Equivalent	Dlp, Inc.
K834039	INFANT VENT CATHETER 12001 W/SIDE VENT	Jan 03, 1984	Substantially Equivalent	Dlp, Inc.
K834025	SARNS CARDIOPLEGIA CANNULA Y	Jan 03, 1984	Substantially Equivalent	3M Health Care, Sarns
K833112	TUBING FOR CARDIOPULMONARY BYPASS	Nov 28, 1983	Substantially Equivalent	Cardio Med Supplies, Inc.
K832475	AXIOM PERFUSSION CANNULA	Oct 19, 1983	Substantially Equivalent	Axiom Medical, Inc.
K832124	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	Aug 12, 1983	Substantially Equivalent	Med-West, Inc.
K831769	VARIOUS CARDIOVASCULAR SURGICAL DEVICE	Aug 12, 1983	Substantially Equivalent	Research Industries Corp.
K831759	INTRACARDIA SUCKERS	Aug 12, 1983	Substantially Equivalent	Research Industries Corp.
K831130	DISPOS. ABODOMINAL RETRACTING PAD	Aug 12, 1983	Substantially Equivalent	Product Development Corp.
K831330	UNIVERSAL CORONARY CANNULA	Aug 10, 1983	Substantially Equivalent	Possis Medical, Inc.
K831591	AORTIC ROOT CANNULA W/INTEGRAL PRESS	Jun 30, 1983	Substantially Equivalent	Dlp, Inc.
K831332	ARGYLE DUAL STAGE VENOUS RETURN CATH.	Jun 30, 1983	Substantially Equivalent	Sherwood Medical Co.
K830728	CARDIOVASCULAR DISPOSABLE PRODUCTS	Apr 28, 1983	Substantially Equivalent	Electromics, Inc.
K822317	ARGYLE CAROTID ARTERY LOOP SHUNT	Aug 31, 1982	Substantially Equivalent	Sherwood Medical Co.
K822210	SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES	Aug 24, 1982	Substantially Equivalent	3M Health Care, Sarns
K821316	KONTRON LITWAK-KOFFSKY OBTURATED CANNU	Aug 06, 1982	Substantially Equivalent	Kontron Instruments, Inc.
K821445	ARGYLE FERGUSON LEFT ATRIAL VENT CATH	Jul 30, 1982	Substantially Equivalent	Sherwood Medical Co.
K821149	SUBMISSION CORONARY CANNULA	May 18, 1982	Substantially Equivalent	Dlp, Inc.
K813037	FLOWGUARD CATHETERS & CANNALAE	Dec 14, 1981	Substantially Equivalent	Advocacy International, Ltd.
K810515	DISPOSABLE 2-STAGE CANNULA	Apr 23, 1981	Substantially Equivalent	Texas Medical Products, Inc.
K810820	CARDIOPULMONARY BYPASS	Apr 03, 1981	Substantially Equivalent	Dlp, Inc.
K810548	CARDIOPULMINARY BYPASS CATHETER CANNULA	Mar 17, 1981	Substantially Equivalent	Dlp, Inc.
K810415	SARNS TWO-STATE WIRE REINFORCED CATHETER	Mar 17, 1981	Substantially Equivalent	3M Health Care, Sarns
K802543	RIDGID VENA CAVA CANNULAE	Jan 16, 1981	Substantially Equivalent	Texas Medical Products, Inc.
K802378	QUICK PRIME LINES, #'S BPL-12, BPL-48 &	Oct 10, 1980	Substantially Equivalent	Bentley Laboratories, Inc.
K802261	PRESSURE GAUGE ACCESSORY KIT/DILATATION	Oct 03, 1980	Substantially Equivalent	Stanco Medical, Inc.
K801770	ARTERIAL BUBBLE TRAP	Aug 07, 1980	Substantially Equivalent	Delta Medical Industries
K801359	PRUITT VASCULAR SHUNT	Jul 28, 1980	Substantially Equivalent	Ideas For Medicine, Inc.
K801403	DISPOSABLE PERFUSION SET	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K801401	CARDIOPULMONARY BYPASS TUBING	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K801398	AORTIC AND FEMORAL PERFUSION CANNULAE	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K801397	VENA CAVA CANNULAE	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K801396	SAPHENOUS VEIN CANNULAE	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K801392	DISPOSABLE SUMP SETS	Jun 30, 1980	Substantially Equivalent	Texas Medical Products, Inc.
K792070	SARNS MEDIASTINAL AND PERICARDIAL TUBE	Nov 21, 1979	Substantially Equivalent	3M Health Care, Sarns
K792202	TROCAR CATHETER/THORACIC CATHETER	Nov 20, 1979	Substantially Equivalent	Portex, Inc.
K792152	CARDIOPLEGIA SOLUTION ADMIN. SET	Nov 13, 1979	Substantially Equivalent	Cardio Systems, Inc.
K791947	SHILEY CARDIOPLEGIC SOLUTION DEL SETS	Nov 13, 1979	Substantially Equivalent	Shiley, Inc.
K791858	CARDIOPLEGIA ADMIN. SETS	Oct 26, 1979	Substantially Equivalent	Travenol Laboratories, S.A.
K791972	ARGYLE PEDIATRIC VENA CAVAL CATHETER	Oct 11, 1979	Substantially Equivalent	Sherwood Medical Co.
K791832	VEIN GRAFT CANNULA	Oct 04, 1979	Substantially Equivalent	D/P, Inc.
K790565	AORTIC ROOT CANNULA	Jun 11, 1979	Substantially Equivalent	Dlp, Inc.
K790246	SARNS WIRE-REINFORCED VENOUS RETURN CAN	Mar 02, 1979	Substantially Equivalent	3M Health Care, Sarns
K781990	CARDIAC INSULATION PAD	Dec 04, 1978	Substantially Equivalent	Shiley, Inc.
K771692	TUBING SETS	Oct 04, 1977	Substantially Equivalent	Cobe Laboratories, Inc.
K771499	FLEXIBLE ARTERIAL CANNULAE	Aug 16, 1977	Substantially Equivalent	3M Health Care, Sarns
K770431	CATHETER, TWO STAGE VENOUS RETURN	Mar 16, 1977	Substantially Equivalent	3M Health Care, Sarns
K770430	CATHETER, CURVED LEFT HEART VENT	Mar 16, 1977	Substantially Equivalent	3M Health Care, Sarns
K770429	CANNULAE, AORTIC, ARCH, HIGH FLOW	Mar 16, 1977	Substantially Equivalent	3M Health Care, Sarns
K770068	CANNULA, HUNTER-SESSIONS, SELF-RETAIN.	Mar 01, 1977	Substantially Equivalent	Barlow Mfg., Corp.