Product Code: DTN FDA class 2 21 CFR 870.4400

Reservoir, Blood, Cardiopulmonary Bypass

Cardiovascular

The Cardiopulmonary Bypass Blood Reservoir is a cardiovascular device that temporarily stores venous blood collected from the patient during extracorporeal bypass, allowing the perfusionist to manage blood volume and prevent air entrainment in the circuit 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 DTN and it is regulated under 21 CFR 870.4400 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

169

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DTN
Device Class: FDA class 2
Regulation Number: 870.4400
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 169 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251783	Inspire HCR and HCR DUAL cardiotomy reservoirs	Dec 22, 2025	Substantially Equivalent	Sorin Group Italia S.R.L.
K241206	Quantum Perfusion Hybrid System	Jul 18, 2024	Substantially Equivalent	Spectrum Medical S.R.L.
K241053	MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL	May 15, 2024	Substantially Equivalent	Medtronic Cardiac Surgery
K223361	BMR 1900 PHISIO	Jun 10, 2023	Substantially Equivalent	Sorin Group Italia S.R.L.
K170583	Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface	Mar 17, 2017	Substantially Equivalent	Medtronic, Inc.
K161733	INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C	Mar 08, 2017	Substantially Equivalent	Sorin Group Italia S.R.L.
K153143	Capiox Advance Hardshell Reservoir	Dec 02, 2015	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K151110	Intersept Filtered Cardiotomy Reservoir	May 27, 2015	Substantially Equivalent	Medtronic, Inc.
K141432	NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH	Jul 07, 2014	Substantially Equivalent	Maquet Cardiopulmonary, AG
K141233	AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE	Jun 12, 2014	Substantially Equivalent	Medtronic, Inc.
K140321	INITARY BETTER BLADDER-PEDIATRIC	Apr 17, 2014	Substantially Equivalent	Circulatory Technology, Inc.
K132166	VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT	Oct 30, 2013	Substantially Equivalent	Maquet Cardiopulmonary, AG
K132972	AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE	Oct 28, 2013	Substantially Equivalent	Medtronic, Inc.
K131103	XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR	Jun 06, 2013	Substantially Equivalent	Sorin Group Italia S.R.L.
K122914	AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE	Jan 09, 2013	Substantially Equivalent	Medtronic, Inc.
K112771	BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG	Oct 14, 2011	Substantially Equivalent	Sorin Group Italia S.R.L.
K102919	NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE	Mar 11, 2011	Substantially Equivalent	Maquet Cardiopulmonary, AG
K100507	XRES BLOOD COLLECTION RESERVOIR	Mar 24, 2010	Substantially Equivalent	Sorin Group Italia S.R.L.
K090690	VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING	Dec 23, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K090534	VENOUS HARDSHELL CARDIOTOMY RESERVIORS	Dec 23, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K092315	SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR	Aug 12, 2009	Substantially Equivalent	Sorin Group Italia S.R.L.
K091062	MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730	Aug 04, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K083131	MEDOS HILITE RESERVOIR, MODEL: 4030	Jul 30, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K082082	GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING	Feb 04, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K081947	GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING	Feb 04, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K070605	JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING	Jan 04, 2008	Substantially Equivalent	Maquet Cardiopulmonary, AG
K072697	3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES	Dec 20, 2007	Substantially Equivalent	3t Medical Systems, LLC
K070839	MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR	Apr 24, 2007	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K061743	VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001	Jul 21, 2006	Substantially Equivalent	Maquet Cardiopulmonary, AG
K061527	CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING	Jun 27, 2006	Substantially Equivalent	Sorin Group Italia S.R.L.
K051606	GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING	Aug 12, 2005	Substantially Equivalent	Gish Biomedical, Inc.
K050195	V-BAG WITH GBS COATING	Mar 17, 2005	Substantially Equivalent	Gish Biomedical, Inc.
K050111	SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG	Mar 08, 2005	Substantially Equivalent	Cobe Cardiovascular, Inc.
K040023	CAPIOX FLEXIBLE VENOUS RESERVOIR	Mar 01, 2004	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K033800	CAPIOX CARDIOTOMY RESERVOIR	Feb 10, 2004	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K033714	MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING	Dec 11, 2003	Substantially Equivalent	Dideco S.P.A.
K033641	SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800	Dec 11, 2003	Substantially Equivalent	Cobe Cardiovascular, Inc.
K031700	MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711	Aug 29, 2003	Substantially Equivalent	Medtronic Perfusion Systems
K031150	HEMOBAG, MODEL HBBSD2000	Jun 23, 2003	Substantially Equivalent	Global Blood Resources, LLC
K030726	GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING	May 30, 2003	Substantially Equivalent	Gish Biomedical, Inc.
K030449	MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR	Mar 05, 2003	Substantially Equivalent	Terumo Corp.
K024065	SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING	Mar 05, 2003	Substantially Equivalent	Gish Biomedical, Inc.
K022281	SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045	Aug 06, 2002	Substantially Equivalent	Polystan A/S
K021287	TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT	May 07, 2002	Substantially Equivalent	Medtronic Perfusion Systems
K013526	CAPIOX RX HARDSHELL RESERVOIR	Nov 15, 2001	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K012942	THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500	Nov 05, 2001	Substantially Equivalent	Circulatory Technology, Inc.
K003551	VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201	Jul 11, 2001	Substantially Equivalent	Jostra AG
K011864	TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B	Jul 09, 2001	Substantially Equivalent	Medtronic Vascular
K002496	MODEL 4815 ADAPTER	Oct 10, 2000	Substantially Equivalent	Pace Medical
K002238	CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING	Aug 22, 2000	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K001822	THE V-BAG	Jul 07, 2000	Substantially Equivalent	Circulatory Technology, Inc.
K001602	DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)	Jun 08, 2000	Substantially Equivalent	Dideco S.P.A.
K994389	COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED	Mar 27, 2000	Substantially Equivalent	Cobe Cardiovascular, Inc.
K993001	COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED	Dec 03, 1999	Substantially Equivalent	Cobe Cardiovascular, Inc.
K992599	DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR	Nov 01, 1999	Substantially Equivalent	Dideco S.P.A.
K991973	CAPIOX SX10 HARDSHELL RESEVOIR	Sep 03, 1999	Substantially Equivalent	Terumo Medical Corp.
K984586	FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS	Jun 29, 1999	Substantially Equivalent	Fresenius Hemotechnology, Inc.
K990239	COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR	May 25, 1999	Substantially Equivalent	Cobe Cardiovascular, Inc.
K982136	JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200	Mar 24, 1999	Substantially Equivalent	Schiff & Co.
K984456	COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR	Jan 11, 1999	Substantially Equivalent	Cobe Cardiovascular, Inc.
K982223	CAPIOX SX HARDSHELL RESEVOIR	Sep 10, 1998	Substantially Equivalent	Terumo Medical Corp.
K980786	COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800	Aug 24, 1998	Substantially Equivalent	Cobe Cardiovascular, Inc.
K981284	BETTER-BLADDER (BB)	Aug 12, 1998	Substantially Equivalent	Circulatory Technology, Inc.
K981628	BARD QUANTUM SVR MODEL NUMBER H-6440VR	Aug 05, 1998	Substantially Equivalent	C.R. Bard, Inc.
K980935	CAPIOX SX HARDSHELL RESERVOIR	May 14, 1998	Substantially Equivalent	Terumo Medical Corp.
K974155	BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT	Jan 22, 1998	Substantially Equivalent	Baxter Healthcare Corp
K971013	CHASE TEMPERATURE PROBE	Oct 28, 1997	Substantially Equivalent	Chase Medical, Inc.
K972017	BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)	Sep 10, 1997	Substantially Equivalent	Minntech Corp.
K964908	VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER	Sep 03, 1997	Substantially Equivalent	Sorin Biomedical, Inc.
K964907	VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT	Aug 21, 1997	Substantially Equivalent	Sorin Biomedical, Inc.
K971669	COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR	Jul 23, 1997	Substantially Equivalent	Cobe Cardiovascular, Inc.
K971105	MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM	Jul 11, 1997	Substantially Equivalent	Avecor Cardiovascular, Inc.
K964973	GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR	Mar 10, 1997	Substantially Equivalent	Gish Biomedical, Inc.
K961836	MAXIMA FORTE HARDSHELL VENOUS RESERVOIR	Nov 01, 1996	Substantially Equivalent	Medtronic Vascular
K953821	BIOCOR 200 HARDSHELL VENOUS RESERVIOR	Mar 07, 1996	Substantially Equivalent	Minntech Corp.
K955046	SOFT VENOUS RESERVOIR	Jan 11, 1996	Substantially Equivalent	Gish Biomedical, Inc.
K945065	DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063	May 19, 1995	Substantially Equivalent	Sorin Biomedical, Inc.
K941215	VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR	May 10, 1995	Substantially Equivalent	Sorin Biomedical, Inc.
K936003	AFFINITY CVR	Jun 20, 1994	Substantially Equivalent	Avecor Cardiovascular, Inc.
K935717	AFFINITY VENOUS RESERVIOR BAG	May 10, 1994	Substantially Equivalent	Avecor Cardiovascular, Inc.
K934847	NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS	Apr 15, 1994	Substantially Equivalent	Sorin Biomedical, Inc.
K934763	SORIN BLOOD CARDIOPLEGIA SYSTEM	Apr 15, 1994	Substantially Equivalent	Sorin Biomedical, Inc.
K936183	SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS	Mar 23, 1994	Substantially Equivalent	Sorin Biomedical, Inc.
K933713	VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT	Mar 01, 1994	Substantially Equivalent	Baxter Healthcare Corp
K936286	ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)	Feb 14, 1994	Substantially Equivalent	Gish Biomedical, Inc.
K933481	SORIN MONOLYTH VENOUS RESERVOIR	Nov 02, 1993	Substantially Equivalent	Sorin Biomedical, Inc.
K930154	EL2-SERIES BLOOD COLLECTION REERVOIR	Jul 01, 1993	Substantially Equivalent	Electromedics, Inc.
K930299	BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET	Jun 22, 1993	Substantially Equivalent	C.R. Bard, Inc.
K920178	CARDIOTOMY RESERVOIR W/20 MICRON FILITER	May 13, 1993	Substantially Equivalent	Lifestream Int'L, Inc.
K925046	PLEUR-EVAC CARDIOTOMY RESERVOIR	Apr 20, 1993	Substantially Equivalent	Deknatel, Inc.
K926250	ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR	Feb 19, 1993	Substantially Equivalent	Electromedics, Inc.
K915573	VENOUS RESERVOIR W/CARDIOTOMY FILTER	Dec 23, 1992	Substantially Equivalent	Baxter Healthcare Corp
K920774	MVR COLLAPSIBLE VENOUS RESERVOIR BAG	Oct 19, 1992	Substantially Equivalent	Medtronic Vascular
K920312	NEW COBE CARDIOPLEGIA SYSTEM	Oct 01, 1992	Substantially Equivalent	Cobe Cardiovascular, Inc.
K915737	AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR	Sep 03, 1992	Substantially Equivalent	Electromedics, Inc.
K913915	BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV	Jan 21, 1992	Substantially Equivalent	Bard Cardiosurgery Div
K913956	BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30	Jan 17, 1992	Substantially Equivalent	Bentley Laboratories, Inc.
K913692	VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)	Nov 15, 1991	Substantially Equivalent	Bentley Laboratories, Inc.
K911790	MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG	Aug 12, 1991	Substantially Equivalent	Medtronic Vascular
K911876	SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200	Aug 09, 1991	Substantially Equivalent	Shiley, Inc.
K905818	VACUUM-ASSISTED BLOOD COLLECTION SYSTEM	Jun 06, 1991	Substantially Equivalent	Jtl Medical Corp.
K903632	INTERSEPT 1375 VENOUS RESERVOIR	Dec 17, 1990	Substantially Equivalent	Medtronic Vascular
K902631	COBE ICU CONVERSION KIT	Dec 17, 1990	Substantially Equivalent	Cobe Laboratories, Inc.
K904040	SOFTSHELL VENOUS RESERVOIR	Dec 06, 1990	Substantially Equivalent	C.R. Bard, Inc.
K894664	CAPIOX HARDSHELL VENOUS RESERVOIR	Apr 20, 1990	Substantially Equivalent	Terumo Medical Corp.
K895356	UNIVOX-IC	Mar 06, 1990	Substantially Equivalent	Baxter Healthcare Corp
K893711	DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR	Feb 28, 1990	Substantially Equivalent	Shiley, Inc.
K896414	VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN	Jan 31, 1990	Substantially Equivalent	Baxter Healthcare Corp
K893705	SAFE-1 VENOUS RESERVOIR	Dec 22, 1989	Substantially Equivalent	Polystan C/O Vitalcor, Inc.
K895076	CMS VRB-1200	Nov 03, 1989	Substantially Equivalent	Cobe Laboratories, Inc.
K890077	TRAUMAFUSE RAPID INFUSION DEVICE	Apr 03, 1989	Substantially Equivalent	The Traumafuse Co.
K884872	DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR	Jan 30, 1989	Substantially Equivalent	Shiley, Inc.
K882414	BLOOD RESERVOIR, CARDIOPULMONARY BYPASS	Dec 05, 1988	Substantially Equivalent	Gish Biomedical, Inc.
K883923	CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES	Nov 04, 1988	Substantially Equivalent	Gish Biomedical, Inc.
K882380	SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR	Oct 06, 1988	Substantially Equivalent	Scimed Life Systems, Inc.
K883345	SARNS INFANT VENOUS RESERVOIR MODEL #16387	Sep 28, 1988	Substantially Equivalent	3M Health Care, Sarns
K882720	SCIMED R30 SILICONE ASSIST RESERVOIR	Sep 16, 1988	Substantially Equivalent	Scimed Life Systems, Inc.
K873423	MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER	Nov 06, 1987	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K872719	EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER	Sep 30, 1987	Substantially Equivalent	Shiley, Inc.
K872722	EXPANDED USE FOR SHILEY 3L CARDF PLUS	Sep 23, 1987	Substantially Equivalent	Shiley, Inc.
K872721	EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR	Sep 23, 1987	Substantially Equivalent	Shiley, Inc.
K872720	SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET	Sep 23, 1987	Substantially Equivalent	Shiley, Inc.
K872378	WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR	Sep 14, 1987	Substantially Equivalent	C.R. Bard, Inc.
K871775	STAT-VAC CHEST DRAINAGE SYSTEM	Jun 24, 1987	Substantially Equivalent	Gish Biomedical, Inc.
K870829	SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR	May 06, 1987	Substantially Equivalent	3M Health Care, Sarns
K864895	INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER	Feb 19, 1987	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K862920	BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR	Sep 29, 1986	Substantially Equivalent	C.R. Bard, Inc.
K862357	MODIFIED CARDIOTOMY RESERVOIR 5M1470	Aug 19, 1986	Substantially Equivalent	3M Health Care, Sarns
K854841	SHILEY VENOUS RESERVOIR	Feb 10, 1986	Substantially Equivalent	Shiley, Inc.
K852382	CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR	Sep 25, 1985	Substantially Equivalent	American Bentley
K851401	VENUOS RESERVOIR BAG BMR-1900	Jun 25, 1985	Substantially Equivalent	American Bentley
K851376	VENOUS RESERVOIR BAG BMR-1600	Jun 25, 1985	Substantially Equivalent	American Bentley
K842391	ACR 2500 CARDIOTOMY RESERVOIR FILTER	May 21, 1985	Substantially Equivalent	Electromedics, Inc.
K843888	CARDIOTOMY RESERVOIR BRS-XXX SERIES &	Feb 14, 1985	Substantially Equivalent	Gish Biomedical, Inc.
K843595	CARDIOTOMY RESERVOIR W/FILTER	Feb 14, 1985	Substantially Equivalent	Omnis Surgical, Inc.
K844367	CARDIOTOMY RESERVOIR W/FILTER BCR-2500	Jan 14, 1985	Substantially Equivalent	American Bentley
K844366	CARDIOTOMY RESERVOIR BCR-2000	Jan 14, 1985	Substantially Equivalent	American Bentley
K844229	VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX	Jan 14, 1985	Substantially Equivalent	Gish Biomedical, Inc.
K843232	SHILEY HARDSHELL VENOUS RESERVOIR W/INT	Jan 14, 1985	Substantially Equivalent	Shiley, Inc.
K842620	CARDIOTOMY RESERVOIR W/FILTER BCR-3500	Aug 27, 1984	Substantially Equivalent	American Bentley
K842337	SHILEY VENOUS RESERVOIR	Aug 17, 1984	Substantially Equivalent	Shiley, Inc.
K842711	SHILEY CARDIOTOMY RESERVOIR W/FILTER	Aug 10, 1984	Substantially Equivalent	Shiley, Inc.
K841938	CARDIOPLEGIA RESERVOIR CAS-2000	Aug 03, 1984	Substantially Equivalent	American Bentley
K841031	OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT	May 23, 1984	Substantially Equivalent	American Bentley
K841175	WILLIAM HARVEY H-4720 NON-FILTERED CAR	Apr 25, 1984	Substantially Equivalent	C.R. Bard, Inc.
K841079	WILLIAM HARVEY H-4700 FILTER/CARDIO	Apr 17, 1984	Substantially Equivalent	C.R. Bard, Inc.
K834373	CARDIOTOMY RESERVORS BCR-3000/3500-Q-120	Feb 04, 1984	Substantially Equivalent	American Bentley
K832802	USE OF TWEEN 80 AS A WETTING AGENT ON	Dec 29, 1983	Substantially Equivalent	American Bentley
K832671	CARDIOTOMY RESERVOIR-FILTER 050-108-050	Dec 27, 1983	Substantially Equivalent	Cobe Laboratories, Inc.
K833479	WILLIAM HARVEY H-71-5-F CARDIOTOMY	Dec 16, 1983	Substantially Equivalent	C.R. Bard, Inc.
K832924	VENOUS RESERVOIR	Oct 31, 1983	Substantially Equivalent	Shiley, Inc.
K831966	CARDIOPLEGIA RESERVOIR-#500926	Aug 11, 1983	Substantially Equivalent	American Bentley
K823272	VENOUS RESERVOIR BAG #BMR-1400	Dec 30, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K823205	EXV VENOUS RESERVOIR BAG & HOLDER	Nov 24, 1982	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K820727	CARDIOTOMY RESERVOIRS	Jul 08, 1982	Substantially Equivalent	Erik Perfusion Services
K821442	WILLIAM HARVEY FLEX. VENOUS RESERVOIR	Jun 17, 1982	Substantially Equivalent	C.R. Bard, Inc.
K813268	SC-2500F CARDIOTOMY RESERVIOR	May 18, 1982	Substantially Equivalent	Scimed Life Systems, Inc.
K812455	SUCKER CARDIOTOMY RETURN, C.P. BYPASS	Oct 23, 1981	Substantially Equivalent	Electromedics, Inc.
K812009	CARDIOTOMY RESERVOIR W/FILTER#BCR-3500	Jul 28, 1981	Substantially Equivalent	Bentley Laboratories, Inc.
K812008	CORDIOTOMY RESERVOIR	Jul 28, 1981	Substantially Equivalent	Bentley Laboratories, Inc.
K802890	CPS-1000	Mar 05, 1981	Substantially Equivalent	Gics Pharmaceuticals
K803059	INTERSEPT* VENOUS RESERVOIR BAG & HOLDER	Dec 22, 1980	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K802119	SHILEY UTILITY RESERVOIR	Sep 16, 1980	Substantially Equivalent	Shiley, Inc.
K790635	Q220F CARDITOMY RESERVOIR/MODIFIED	Apr 18, 1979	Substantially Equivalent	Bentley Laboratories, Inc.
K781577	DISPOSABLE CARDIOTOMY; H-700F, H-700	Sep 27, 1978	Substantially Equivalent	C.R. Bard, Inc.
K780517	CARDIOTOMY RESERVOIR	Apr 13, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K770546	BLOOD RESERVOIR	Apr 26, 1977	Substantially Equivalent	Delta Medical Industries
K770036	CARDIOTOMY RESERVOIR	Jan 14, 1977	Substantially Equivalent	Shiley, Inc.
K760823	TMO OXYGENATOR RESERVOIR PUMP SET	Nov 12, 1976	Substantially Equivalent	Travenol Laboratories, S.A.