FDA 510(k) Applications for Medical Device Product Code "DTN"
(Reservoir, Blood, Cardiopulmonary Bypass)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K072697 | 3T MEDICAL SYSTEMS, LLC | 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES | 12/20/2007 |
| K971105 | AVECOR CARDIOVASCULAR, INC. | MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM | 07/11/1997 |
| K974155 | BAXTER HEALTHCARE CORP. | BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT | 01/22/1998 |
| K981628 | C.R. BARD, INC. | BARD QUANTUM SVR MODEL NUMBER H-6440VR | 08/05/1998 |
| K971013 | CHASE MEDICAL, INC. | CHASE TEMPERATURE PROBE | 10/28/1997 |
| K981284 | CIRCULATORY TECHNOLOGY, INC. | BETTER-BLADDER (BB) | 08/12/1998 |
| K140321 | CIRCULATORY TECHNOLOGY, INC. | INITARY BETTER BLADDER-PEDIATRIC | 04/17/2014 |
| K012942 | CIRCULATORY TECHNOLOGY, INC. | THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 | 11/05/2001 |
| K001822 | CIRCULATORY TECHNOLOGY, INC. | THE V-BAG | 07/07/2000 |
| K980786 | COBE CARDIOVASCULAR, INC. | COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 | 08/24/1998 |
| K994389 | COBE CARDIOVASCULAR, INC. | COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED | 03/27/2000 |
| K971669 | COBE CARDIOVASCULAR, INC. | COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR | 07/23/1997 |
| K984456 | COBE CARDIOVASCULAR, INC. | COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | 01/11/1999 |
| K993001 | COBE CARDIOVASCULAR, INC. | COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED | 12/03/1999 |
| K990239 | COBE CARDIOVASCULAR, INC. | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | 05/25/1999 |
| K050111 | COBE CARDIOVASCULAR, INC. | SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG | 03/08/2005 |
| K033641 | COBE CARDIOVASCULAR, INC. | SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 | 12/11/2003 |
| K992599 | DIDECO S.P.A. | DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR | 11/01/1999 |
| K001602 | DIDECO S.P.A. | DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) | 06/08/2000 |
| K033714 | DIDECO S.P.A. | MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING | 12/11/2003 |
| K984586 | FRESENIUS HEMOTECHNOLOGY, INC. | FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS | 06/29/1999 |
| K051606 | GISH BIOMEDICAL, INC. | GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING | 08/12/2005 |
| K964973 | GISH BIOMEDICAL, INC. | GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR | 03/10/1997 |
| K030726 | GISH BIOMEDICAL, INC. | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING | 05/30/2003 |
| K081947 | GISH BIOMEDICAL, INC. | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING | 02/04/2009 |
| K082082 | GISH BIOMEDICAL, INC. | GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING | 02/04/2009 |
| K091062 | GISH BIOMEDICAL, INC. | MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 | 08/04/2009 |
| K083131 | GISH BIOMEDICAL, INC. | MEDOS HILITE RESERVOIR, MODEL: 4030 | 07/30/2009 |
| K955046 | GISH BIOMEDICAL, INC. | SOFT VENOUS RESERVOIR | 01/11/1996 |
| K024065 | GISH BIOMEDICAL, INC. | SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING | 03/05/2003 |
| K050195 | GISH BIOMEDICAL, INC. | V-BAG WITH GBS COATING | 03/17/2005 |
| K031150 | GLOBAL BLOOD RESOURCES, LLC | HEMOBAG, MODEL HBBSD2000 | 06/23/2003 |
| K003551 | JOSTRA AG | VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 | 07/11/2001 |
| K070605 | MAQUET CARDIOPULMONARY AG | JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING | 01/04/2008 |
| K141432 | MAQUET CARDIOPULMONARY AG | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH | 07/07/2014 |
| K102919 | MAQUET CARDIOPULMONARY AG | NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE | 03/11/2011 |
| K090534 | MAQUET CARDIOPULMONARY AG | VENOUS HARDSHELL CARDIOTOMY RESERVIORS | 12/23/2009 |
| K061743 | MAQUET CARDIOPULMONARY AG | VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 | 07/21/2006 |
| K132166 | MAQUET CARDIOPULMONARY AG | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT | 10/30/2013 |
| K090690 | MAQUET CARDIOPULMONARY AG | VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING | 12/23/2009 |
| K122914 | MEDTRONIC INC. | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE | 01/09/2013 |
| K031700 | MEDTRONIC PERFUSION SYSTEMS | MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 | 08/29/2003 |
| K021287 | MEDTRONIC PERFUSION SYSTEMS | TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT | 05/07/2002 |
| K961836 | MEDTRONIC VASCULAR | MAXIMA FORTE HARDSHELL VENOUS RESERVOIR | 11/01/1996 |
| K011864 | MEDTRONIC VASCULAR | TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B | 07/09/2001 |
| K151110 | Medtronic, Inc | Intersept Filtered Cardiotomy Reservoir | 05/27/2015 |
| K132972 | MEDTRONIC, INC. | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE | 10/28/2013 |
| K141233 | MEDTRONIC, INC. | AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE | 06/12/2014 |
| K170583 | Medtronic, Inc. | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface | 03/17/2017 |
| K953821 | MINNTECH CORP. | BIOCOR 200 HARDSHELL VENOUS RESERVIOR | 03/07/1996 |
| K972017 | MINNTECH CORP. | BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) | 09/10/1997 |
| K002496 | PACE MEDICAL | MODEL 4815 ADAPTER | 10/10/2000 |
| K022281 | POLYSTAN A/S | SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 | 08/06/2002 |
| K982136 | SCHIFF & CO. | JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 | 03/24/1999 |
| K964907 | SORIN BIOMEDICAL, INC. | VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT | 08/21/1997 |
| K964908 | SORIN BIOMEDICAL, INC. | VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER | 09/03/1997 |
| K161733 | Sorin Group Italia S.r.l | INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C | 03/08/2017 |
| K100507 | SORIN GROUP ITALIA S.R.L | XRES BLOOD COLLECTION RESERVOIR | 03/24/2010 |
| K223361 | Sorin Group Italia S.R.L. | BMR 1900 PHISIO | 06/10/2023 |
| K112771 | SORIN GROUP ITALIA S.R.L. | BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG | 10/14/2011 |
| K061527 | SORIN GROUP ITALIA S.R.L. | CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING | 06/27/2006 |
| K092315 | SORIN GROUP ITALIA S.R.L. | SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR | 08/12/2009 |
| K131103 | SORIN GROUP ITALIA S.R.L. | XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR | 06/06/2013 |
| K040023 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CAPIOX FLEXIBLE VENOUS RESERVOIR | 03/01/2004 |
| K013526 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CAPIOX RX HARDSHELL RESERVOIR | 11/15/2001 |
| K002238 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING | 08/22/2000 |
| K070839 | TERUMO CARDIOVASCULAR SYSTEMS CORP. | MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR | 04/24/2007 |
| K153143 | Terumo Cardiovascular Systems Corporation | Capiox Advance Hardshell Reservoir | 12/02/2015 |
| K033800 | Terumo Cardiovascular Systems Corporation | CAPIOX CARDIOTOMY RESERVOIR | 02/10/2004 |
| K030449 | TERUMO CORP. | MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR | 03/05/2003 |
| K980935 | TERUMO MEDICAL CORP. | CAPIOX SX HARDSHELL RESERVOIR | 05/14/1998 |
| K982223 | TERUMO MEDICAL CORP. | CAPIOX SX HARDSHELL RESEVOIR | 09/10/1998 |
| K991973 | TERUMO MEDICAL CORP. | CAPIOX SX10 HARDSHELL RESEVOIR | 09/03/1999 |
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