FDA Product Code
FDA Product Code DTN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4400
510(k) Clearances — 169 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | Sorin Group Italia S.R.L. | 2025-12-22 | Traditional | PDF ↗ |
| K241206 | Quantum Perfusion Hybrid System | Spectrum Medical S.R.L. | 2024-07-18 | Traditional | PDF ↗ |
| 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 | Medtronic Cardiac Surgery | 2024-05-15 | Special | PDF ↗ |
| K223361 | BMR 1900 PHISIO | Sorin Group Italia S.R.L. | 2023-06-10 | Traditional | PDF ↗ |
| K170583 | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface | Medtronic, Inc. | 2017-03-17 | Special | PDF ↗ |
| K161733 | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C | Sorin Group Italia S.R.L. | 2017-03-08 | Traditional | PDF ↗ |
| K153143 | Capiox Advance Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-12-02 | Special | PDF ↗ |
| K151110 | Intersept Filtered Cardiotomy Reservoir | Medtronic, Inc. | 2015-05-27 | Special | PDF ↗ |
| K141432 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH | Maquet Cardiopulmonary, AG | 2014-07-07 | Special | PDF ↗ |
| K141233 | AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE | Medtronic, Inc. | 2014-06-12 | Special | PDF ↗ |
| K140321 | INITARY BETTER BLADDER-PEDIATRIC | Circulatory Technology, Inc. | 2014-04-17 | Special | PDF ↗ |
| K132166 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT | Maquet Cardiopulmonary, AG | 2013-10-30 | Special | PDF ↗ |
| K132972 | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE | Medtronic, Inc. | 2013-10-28 | Special | PDF ↗ |
| K131103 | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR | Sorin Group Italia S.R.L. | 2013-06-06 | Special | PDF ↗ |
| K122914 | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE | Medtronic, Inc. | 2013-01-09 | Traditional | PDF ↗ |
| K112771 | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG | Sorin Group Italia S.R.L. | 2011-10-14 | Special | PDF ↗ |
| K102919 | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE | Maquet Cardiopulmonary, AG | 2011-03-11 | Traditional | PDF ↗ |
| K100507 | XRES BLOOD COLLECTION RESERVOIR | Sorin Group Italia S.R.L. | 2010-03-24 | Special | PDF ↗ |
| K090690 | VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | 2009-12-23 | Special | PDF ↗ |
| K090534 | VENOUS HARDSHELL CARDIOTOMY RESERVIORS | Maquet Cardiopulmonary, AG | 2009-12-23 | Special | PDF ↗ |
| K092315 | SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR | Sorin Group Italia S.R.L. | 2009-08-12 | Special | PDF ↗ |
| K091062 | MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 | Gish Biomedical, Inc. | 2009-08-04 | Traditional | PDF ↗ |
| K083131 | MEDOS HILITE RESERVOIR, MODEL: 4030 | Gish Biomedical, Inc. | 2009-07-30 | Traditional | PDF ↗ |
| K082082 | GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING | Gish Biomedical, Inc. | 2009-02-04 | Traditional | PDF ↗ |
| K081947 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING | Gish Biomedical, Inc. | 2009-02-04 | Traditional | PDF ↗ |
| K070605 | JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING | Maquet Cardiopulmonary, AG | 2008-01-04 | Traditional | PDF ↗ |
| K072697 | 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES | 3t Medical Systems, LLC | 2007-12-20 | Traditional | PDF ↗ |
| K070839 | MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR | Terumo Cardiovascular Systems Corp. | 2007-04-24 | Special | PDF ↗ |
| K061743 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 | Maquet Cardiopulmonary, AG | 2006-07-21 | Special | PDF ↗ |
| K061527 | CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING | Sorin Group Italia S.R.L. | 2006-06-27 | Special | PDF ↗ |
| K051606 | GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING | Gish Biomedical, Inc. | 2005-08-12 | Traditional | PDF ↗ |
| K050195 | V-BAG WITH GBS COATING | Gish Biomedical, Inc. | 2005-03-17 | Traditional | PDF ↗ |
| K050111 | SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG | Cobe Cardiovascular, Inc. | 2005-03-08 | Abbreviated | PDF ↗ |
| K040023 | CAPIOX FLEXIBLE VENOUS RESERVOIR | Terumo Cardiovascular Systems Corp. | 2004-03-01 | Traditional | PDF ↗ |
| K033800 | CAPIOX CARDIOTOMY RESERVOIR | Terumo Cardiovascular Systems Corporation | 2004-02-10 | Traditional | PDF ↗ |
| K033641 | SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 | Cobe Cardiovascular, Inc. | 2003-12-11 | Special | PDF ↗ |
| K033714 | MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING | Dideco S.P.A. | 2003-12-11 | Special | PDF ↗ |
| K031700 | MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 | Medtronic Perfusion Systems | 2003-08-29 | Traditional | PDF ↗ |
| K031150 | HEMOBAG, MODEL HBBSD2000 | Global Blood Resources, LLC | 2003-06-23 | Traditional | PDF ↗ |
| K030726 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING | Gish Biomedical, Inc. | 2003-05-30 | Traditional | PDF ↗ |
| K030449 | MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR | Terumo Corp. | 2003-03-05 | Special | PDF ↗ |
| K024065 | SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING | Gish Biomedical, Inc. | 2003-03-05 | Traditional | PDF ↗ |
| K022281 | SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 | Polystan A/S | 2002-08-06 | Traditional | PDF ↗ |
| K021287 | TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT | Medtronic Perfusion Systems | 2002-05-07 | Special | PDF ↗ |
| K013526 | CAPIOX RX HARDSHELL RESERVOIR | Terumo Cardiovascular Systems Corp. | 2001-11-15 | Special | PDF ↗ |
| K012942 | THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 | Circulatory Technology, Inc. | 2001-11-05 | Traditional | PDF ↗ |
| K003551 | VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 | Jostra AG | 2001-07-11 | Traditional | PDF ↗ |
| K011864 | TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B | Medtronic Vascular | 2001-07-09 | Special | PDF ↗ |
| K002496 | MODEL 4815 ADAPTER | Pace Medical | 2000-10-10 | Traditional | PDF ↗ |
| K002238 | CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING | Terumo Cardiovascular Systems Corp. | 2000-08-22 | Special | PDF ↗ |
| K001822 | THE V-BAG | Circulatory Technology, Inc. | 2000-07-07 | Traditional | PDF ↗ |
| K001602 | DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) | Dideco S.P.A. | 2000-06-08 | Special | PDF ↗ |
| K994389 | COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED | Cobe Cardiovascular, Inc. | 2000-03-27 | Traditional | PDF ↗ |
| K993001 | COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED | Cobe Cardiovascular, Inc. | 1999-12-03 | Traditional | PDF ↗ |
| K992599 | DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR | Dideco S.P.A. | 1999-11-01 | Abbreviated | PDF ↗ |
| K991973 | CAPIOX SX10 HARDSHELL RESEVOIR | Terumo Medical Corp. | 1999-09-03 | Traditional | PDF ↗ |
| K984586 | FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS | Fresenius Hemotechnology, Inc. | 1999-06-29 | Traditional | PDF ↗ |
| K990239 | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | 1999-05-25 | Traditional | PDF ↗ |
| K982136 | JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 | Schiff & Co. | 1999-03-24 | Traditional | PDF ↗ |
| K984456 | COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | 1999-01-11 | Special | PDF ↗ |
| K982223 | CAPIOX SX HARDSHELL RESEVOIR | Terumo Medical Corp. | 1998-09-10 | Traditional | PDF ↗ |
| K980786 | COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 | Cobe Cardiovascular, Inc. | 1998-08-24 | Traditional | PDF ↗ |
| K981284 | BETTER-BLADDER (BB) | Circulatory Technology, Inc. | 1998-08-12 | Traditional | PDF ↗ |
| K981628 | BARD QUANTUM SVR MODEL NUMBER H-6440VR | C.R. Bard, Inc. | 1998-08-05 | Traditional | PDF ↗ |
| K980935 | CAPIOX SX HARDSHELL RESERVOIR | Terumo Medical Corp. | 1998-05-14 | Traditional | PDF ↗ |
| K974155 | BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT | Baxter Healthcare Corp | 1998-01-22 | Traditional | PDF ↗ |
| K971013 | CHASE TEMPERATURE PROBE | Chase Medical, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K972017 | BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) | Minntech Corp. | 1997-09-10 | Traditional | PDF ↗ |
| K964908 | VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER | Sorin Biomedical, Inc. | 1997-09-03 | Traditional | PDF ↗ |
| K964907 | VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT | Sorin Biomedical, Inc. | 1997-08-21 | Traditional | PDF ↗ |
| K971669 | COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K971105 | MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM | Avecor Cardiovascular, Inc. | 1997-07-11 | Traditional | PDF ↗ |
| K964973 | GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR | Gish Biomedical, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K961836 | MAXIMA FORTE HARDSHELL VENOUS RESERVOIR | Medtronic Vascular | 1996-11-01 | Traditional | PDF ↗ |
| K953821 | BIOCOR 200 HARDSHELL VENOUS RESERVIOR | Minntech Corp. | 1996-03-07 | Traditional | PDF ↗ |
| K955046 | SOFT VENOUS RESERVOIR | Gish Biomedical, Inc. | 1996-01-11 | Traditional | PDF ↗ |
| K945065 | DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 | Sorin Biomedical, Inc. | 1995-05-19 | Traditional | PDF ↗ |
| K941215 | VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR | Sorin Biomedical, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K936003 | AFFINITY CVR | Avecor Cardiovascular, Inc. | 1994-06-20 | Traditional | PDF ↗ |
| K935717 | AFFINITY VENOUS RESERVIOR BAG | Avecor Cardiovascular, Inc. | 1994-05-10 | Traditional | PDF ↗ |
| K934847 | NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS | Sorin Biomedical, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K934763 | SORIN BLOOD CARDIOPLEGIA SYSTEM | Sorin Biomedical, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K936183 | SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS | Sorin Biomedical, Inc. | 1994-03-23 | Traditional | PDF ↗ |
| K933713 | VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT | Baxter Healthcare Corp | 1994-03-01 | Traditional | PDF ↗ |
| K936286 | ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) | Gish Biomedical, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K933481 | SORIN MONOLYTH VENOUS RESERVOIR | Sorin Biomedical, Inc. | 1993-11-02 | Traditional | PDF ↗ |
| K930154 | EL2-SERIES BLOOD COLLECTION REERVOIR | Electromedics, Inc. | 1993-07-01 | Traditional | PDF ↗ |
| K930299 | BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET | C.R. Bard, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K920178 | CARDIOTOMY RESERVOIR W/20 MICRON FILITER | Lifestream Int'L, Inc. | 1993-05-13 | Traditional | PDF ↗ |
| K925046 | PLEUR-EVAC CARDIOTOMY RESERVOIR | Deknatel, Inc. | 1993-04-20 | Traditional | PDF ↗ |
| K926250 | ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR | Electromedics, Inc. | 1993-02-19 | Traditional | PDF ↗ |
| K915573 | VENOUS RESERVOIR W/CARDIOTOMY FILTER | Baxter Healthcare Corp | 1992-12-23 | Traditional | PDF ↗ |
| K920774 | MVR COLLAPSIBLE VENOUS RESERVOIR BAG | Medtronic Vascular | 1992-10-19 | Traditional | PDF ↗ |
| K920312 | NEW COBE CARDIOPLEGIA SYSTEM | Cobe Cardiovascular, Inc. | 1992-10-01 | Traditional | PDF ↗ |
| K915737 | AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR | Electromedics, Inc. | 1992-09-03 | Traditional | PDF ↗ |
| K913915 | BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV | Bard Cardiosurgery Div | 1992-01-21 | Traditional | PDF ↗ |
| K913956 | BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 | Bentley Laboratories, Inc. | 1992-01-17 | Traditional | PDF ↗ |
| K913692 | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) | Bentley Laboratories, Inc. | 1991-11-15 | Traditional | PDF ↗ |
| K911790 | MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG | Medtronic Vascular | 1991-08-12 | Traditional | PDF ↗ |
| K911876 | SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 | Shiley, Inc. | 1991-08-09 | Traditional | PDF ↗ |
Product code DTN · Class II · Cardiovascular. Data: openFDA.