ClearanceBrief
Panels › Cardiovascular › Product code DTN · Class 2

Reservoir, Blood, Cardiopulmonary Bypass

Regulation 870.4400

1510(k)s in 12 months (169 all time)
0recalls in 12 months (47 all time)
46recalls that name a 510(k)
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Top companies in DTN

Company510(k)sRecalls
Datascope Corporation022
Gish Biomedical, Inc.160
Medtronic Perfusion Systems214
Shiley, Inc.140
American Bentley110
Circulatory Technology, Inc.47
Cobe Cardiovascular, Inc.92
C.R. Bard, Inc.100
Sorin Biomedical, Inc.80
Sorin Group Italia S.R.L.80
Decided510(k)Device and applicantCode
Dec 22, 2025K251783Inspire HCR and HCR DUAL cardiotomy reservoirs
Sorin Group Italia S.R.L., IT
DTN
Jul 18, 2024K241206Quantum Perfusion Hybrid System
Spectrum Medical S.R.L., IT
DTN
May 15, 2024K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive
Medtronic Cardiac Surgery
DTN
Jun 10, 2023K223361BMR 1900 PHISIO
Sorin Group Italia S.R.L., IT
DTN
Mar 17, 2017K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
Medtronic, Inc.
DTN
Mar 8, 2017K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
Sorin Group Italia S.R.L., IT
DTN
Dec 2, 2015K153143Capiox Advance Hardshell Reservoir
Terumo Cardiovascular Systems Corporation
DTN
May 27, 2015K151110Intersept Filtered Cardiotomy Reservoir
Medtronic, Inc.
DTN
Jul 7, 2014K141432NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
Maquet Cardiopulmonary, AG, DE
DTN
Jun 12, 2014K141233AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE
Medtronic, Inc.
DTN
Apr 17, 2014K140321INITARY BETTER BLADDER-PEDIATRIC
Circulatory Technology, Inc.
DTN
Oct 30, 2013K132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
Maquet Cardiopulmonary, AG, DE
DTN
Oct 28, 2013K132972AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
Medtronic, Inc.
DTN
Jun 6, 2013K131103XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
Sorin Group Italia S.R.L.
DTN
Jan 9, 2013K122914AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
Medtronic, Inc.
DTN
Oct 14, 2011K112771BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
Sorin Group Italia S.R.L.
DTN
Mar 11, 2011K102919NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
Maquet Cardiopulmonary, AG, DE
DTN
Mar 24, 2010K100507XRES BLOOD COLLECTION RESERVOIR
Sorin Group Italia S.R.L.
DTN
Dec 23, 2009K090690VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG, DE
DTN
Dec 23, 2009K090534VENOUS HARDSHELL CARDIOTOMY RESERVIORS
Maquet Cardiopulmonary, AG, DE
DTN
Aug 12, 2009K092315SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
Sorin Group Italia S.R.L.
DTN
Aug 4, 2009K091062MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
Gish Biomedical, Inc.
DTN
Jul 30, 2009K083131MEDOS HILITE RESERVOIR, MODEL: 4030
Gish Biomedical, Inc.
DTN
Feb 4, 2009K082082GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
Gish Biomedical, Inc.
DTN
Feb 4, 2009K081947GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
Gish Biomedical, Inc.
DTN
Jan 4, 2008K070605JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
Maquet Cardiopulmonary, AG, DE
DTN
Dec 20, 2007K0726973T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
3t Medical Systems, LLC
DTN
Apr 24, 2007K070839MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
Terumo Cardiovascular Systems Corp.
DTN
Jul 21, 2006K061743VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001
Maquet Cardiopulmonary, AG, DE
DTN
Jun 27, 2006K061527CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
Sorin Group Italia S.R.L.
DTN
Aug 12, 2005K051606GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
Gish Biomedical, Inc.
DTN
Mar 17, 2005K050195V-BAG WITH GBS COATING
Gish Biomedical, Inc.
DTN
Mar 8, 2005K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
Cobe Cardiovascular, Inc.
DTN
Mar 1, 2004K040023CAPIOX FLEXIBLE VENOUS RESERVOIR
Terumo Cardiovascular Systems Corp.
DTN
Feb 10, 2004K033800CAPIOX CARDIOTOMY RESERVOIR
Terumo Cardiovascular Systems Corporation
DTN
Dec 11, 2003K033714MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
Dideco S.P.A.
DTN
Dec 11, 2003K033641SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
Cobe Cardiovascular, Inc.
DTN
Aug 29, 2003K031700MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
Medtronic Perfusion Systems
DTN
Jun 23, 2003K031150HEMOBAG, MODEL HBBSD2000
Global Blood Resources, LLC
DTN
May 30, 2003K030726GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
Gish Biomedical, Inc.
DTN
Mar 5, 2003K030449MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
Terumo Corp.
DTN
Mar 5, 2003K024065SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
Gish Biomedical, Inc.
DTN
Aug 6, 2002K022281SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
Polystan A/S, DK
DTN
May 7, 2002K021287TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
Medtronic Perfusion Systems
DTN
Nov 15, 2001K013526CAPIOX RX HARDSHELL RESERVOIR
Terumo Cardiovascular Systems Corp.
DTN
Nov 5, 2001K012942THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
Circulatory Technology, Inc.
DTN
Jul 11, 2001K003551VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
Jostra AG
DTN
Jul 9, 2001K011864TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
Medtronic Vascular
DTN
Oct 10, 2000K002496MODEL 4815 ADAPTER
Pace Medical
DTN
Aug 22, 2000K002238CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
Terumo Cardiovascular Systems Corp.
DTN

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