Reservoir, Blood, Cardiopulmonary Bypass
FDA product code DTN · 164 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.4400
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-12 – 2025-12-22
DTN
2025-12-22
DTN
2024-07-18
Quantum Perfusion Hybrid System
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DTN
2024-05-15
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
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DTN
2023-06-10
BMR 1900 PHISIO
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DTN
2017-03-17
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
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DTN
2017-03-08
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
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DTN
2013-10-30
VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
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DTN
2013-10-28
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
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DTN
2013-06-06
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
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DTN
2013-01-09
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
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DTN
2011-10-14
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
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DTN
2011-03-11
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
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DTN
2010-03-24
XRES BLOOD COLLECTION RESERVOIR
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DTN
2009-12-23
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
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DTN
2009-12-23
VENOUS HARDSHELL CARDIOTOMY RESERVIORS
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DTN
2009-08-12
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
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DTN
2009-08-04
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
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DTN
2009-07-30
MEDOS HILITE RESERVOIR, MODEL: 4030
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DTN
2009-02-04
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
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DTN
2009-02-04
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
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DTN
2008-01-04
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
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DTN
2007-12-20
3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
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DTN
2007-04-24
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
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DTN
2006-07-21
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001
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DTN
2006-06-27
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
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DTN
2005-08-12
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
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DTN
2005-03-17
V-BAG WITH GBS COATING
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DTN
2005-03-08
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
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DTN
2004-03-01
CAPIOX FLEXIBLE VENOUS RESERVOIR
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DTN
2004-02-10
CAPIOX CARDIOTOMY RESERVOIR
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DTN
2003-12-11
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
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DTN
2003-12-11
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
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DTN
2003-08-29
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
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DTN
2003-06-23
HEMOBAG, MODEL HBBSD2000
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DTN
2003-05-30
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
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DTN
2003-03-05
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
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DTN
2003-03-05
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
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DTN
2002-08-06
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
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DTN
2002-05-07
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
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DTN
2001-11-15
CAPIOX RX HARDSHELL RESERVOIR
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DTN
2001-11-05
THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500
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DTN
2001-07-11
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
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DTN
2001-07-09
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
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DTN
2000-10-10
MODEL 4815 ADAPTER
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DTN
2000-08-22
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
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DTN
2000-07-07
THE V-BAG
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DTN
2000-06-08
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
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DTN
2000-03-27
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
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DTN
1999-12-03
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
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DTN
1999-11-01
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
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DTN
1999-09-03
CAPIOX SX10 HARDSHELL RESEVOIR
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DTN
1999-06-29
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
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DTN
1999-05-25
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
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DTN
1999-03-24
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200
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DTN
1999-01-11
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
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DTN
1998-09-10
CAPIOX SX HARDSHELL RESEVOIR
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DTN
1998-08-24
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
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DTN
1998-08-12
BETTER-BLADDER (BB)
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DTN
1998-08-05
BARD QUANTUM SVR MODEL NUMBER H-6440VR
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DTN
1998-05-14
CAPIOX SX HARDSHELL RESERVOIR
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DTN
1998-01-22
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
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DTN
1997-10-28
CHASE TEMPERATURE PROBE
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DTN
1997-09-10
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
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DTN
1997-09-03
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
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DTN
1997-08-21
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
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DTN
1997-07-23
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
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DTN
1997-07-11
MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
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DTN
1997-03-10
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
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DTN
1996-11-01
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
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DTN
1996-03-07
BIOCOR 200 HARDSHELL VENOUS RESERVIOR
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DTN
1996-01-11
SOFT VENOUS RESERVOIR
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DTN
1995-05-19
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
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DTN
1995-05-10
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
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DTN
1994-06-20
AFFINITY CVR
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DTN
1994-05-10
AFFINITY VENOUS RESERVIOR BAG
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DTN
1994-04-15
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
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DTN
1994-04-15
SORIN BLOOD CARDIOPLEGIA SYSTEM
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DTN
1994-03-23
SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS
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DTN
1994-03-01
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
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DTN
1994-02-14
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
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DTN
1993-11-02
SORIN MONOLYTH VENOUS RESERVOIR
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DTN
1993-07-01
EL2-SERIES BLOOD COLLECTION REERVOIR
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DTN
1993-06-22
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
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DTN
1993-05-13
CARDIOTOMY RESERVOIR W/20 MICRON FILITER
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DTN
1993-04-20
PLEUR-EVAC CARDIOTOMY RESERVOIR
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DTN
1993-02-19
ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
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DTN
1992-12-23
VENOUS RESERVOIR W/CARDIOTOMY FILTER
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DTN
1992-10-19
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
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DTN
1992-10-01
NEW COBE CARDIOPLEGIA SYSTEM
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DTN
1992-09-03
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
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DTN
1992-01-21
BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV
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DTN
1992-01-17
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
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DTN
1991-11-15
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
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DTN
1991-08-12
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
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DTN
1991-08-09
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
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DTN
1991-06-06
VACUUM-ASSISTED BLOOD COLLECTION SYSTEM
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DTN
1990-12-17
INTERSEPT 1375 VENOUS RESERVOIR
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DTN
1990-12-17
COBE ICU CONVERSION KIT
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DTN
1990-12-06
SOFTSHELL VENOUS RESERVOIR
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DTN
1990-04-20
CAPIOX HARDSHELL VENOUS RESERVOIR
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