Product code DTP
- Device name
- Defoamer, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4230
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101186 | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | Medtronic Perfusion Systems | 2010-09-03 |
| K082412 | VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 | Mapquet Cardiopulmonary AG | 2008-11-10 |
| K004046 | COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | 2001-04-26 |
| K002591 | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR | Cobe Cardiovascular, Inc. | 2000-09-13 |
| K990514 | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR | C.R. Bard, Inc. | 1999-03-09 |
| K984322 | DIDECO D920, LILLIPUT 1 TWIN RESERVOIR | Dideco S.P.A. | 1999-03-02 |
| K962726 | BARD QUANTUM CVR | C.R. Bard, Inc. | 1996-10-30 |
| K941654 | SARNS FILTERED VENOUS RESERVIOR MODIFICATION | 3M Health Care, Sarns | 1994-07-26 |
| K933496 | MAXIMA FILTERED HARDSHELL RESERVIOR | Medtronic Vascular | 1993-10-15 |
| K912915 | SARNS NON-FILTERED VENOUS RESERVOIR | 3M Health Care, Ltd. | 1991-09-25 |
| K911789 | MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT | Medtronic Vascular | 1991-08-20 |
| K910568 | MODEL 5866-46 SLEEVE KIT | Medtronic Vascular | 1991-04-09 |
| K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | Cobe Laboratories, Inc. | 1990-12-17 |
| K902856 | BARD FILTERED CARDIOTOMY RESERVOIR | C.R. Bard, Inc. | 1990-09-27 |
| K902355 | MCR4000 & MCR4000F CARDIOTOMY RESERVOIR | Medtronic Vascular | 1990-08-23 |
| K874924 | CAP-35 AND CAP35 F | Gish Biomedical, Inc. | 1988-01-19 |
| K872167 | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | American Bentley | 1987-09-01 |
| K870792 | THORASTAT ATR-XXXX | Gish Biomedical, Inc. | 1987-04-28 |
| K860702 | SARNS FILTERED CARDIOTOMY RESERVOIR | 3M Health Care, Sarns | 1986-05-28 |
| K860775 | MEDIASTINAL AUTOTRANSFUSION SYSTEM | Cardio Metrics, Inc. | 1986-05-28 |
| K855049 | MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR | Scimed Life Systems, Inc. | 1986-02-26 |
| K853503 | SHILEY 3L CARDIOTOMY RESERVOIR | Shiley, Inc. | 1985-11-14 |
| K851004 | CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX | Gish Biomedical, Inc. | 1985-05-16 |
| K844803 | POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE | Electromedics, Inc. | 1985-04-29 |
| K842373 | VENOUS RESERVOIR-BMR-1500-HARD SHELL | American Bentley | 1984-12-27 |
| K840610 | SCIMED MODEL SC4000 | Scimed Life Systems, Inc. | 1984-04-24 |
| K834041 | CARDIOTOMY RESERVOIR SC3500F | Scimed Life Systems, Inc. | 1984-01-30 |
| K832811 | SHILEY 3L CARDF PLUS | Shiley, Inc. | 1983-09-20 |
| K830727 | CARDIOTOMY RESERVOIR-FILTERED & NON | Electromics, Inc. | 1983-04-05 |
| K823731 | CARDF | Shiley, Inc. | 1983-01-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033178113359 | INSPIRE | SORIN GROUP ITALIA SRL | 2021-04-13 |
| 08033178113366 | INSPIRE | SORIN GROUP ITALIA SRL | 2021-04-13 |
| 00699753450868 | NX19 Oxygenator w/4-liter reservoir; right-side outlet port | Terumo Cardiovascular Systems Corporation | 2021-03-18 |
| 00699753450875 | NX19 Oxygenator w/4-liter reservoir; left-side outlet port | Terumo Cardiovascular Systems Corporation | 2021-03-18 |
| 04037691075051 | VBT Venous Bubble Trap | Maquet Cardiopulmonary AG | 2017-03-13 |
| 04037691665733 | MACE | Maquet Cardiopulmonary AG | 2017-03-13 |
| 04037691665726 | MACE | Maquet Cardiopulmonary AG | 2017-03-13 |
| 04037691576350 | MACE | Maquet Cardiopulmonary AG | 2017-03-13 |
| 00643169767645 | Intersept™ | MEDTRONIC, INC. | 2017-02-05 |
| 04037691965628 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-10-24 |
| 04037691209722 | NA | Maquet Cardiopulmonary AG | 2015-10-24 |
| 04037691780542 | QUADROX-i | Maquet Cardiopulmonary AG | 2015-10-24 |
| 04037691833545 | NA | Maquet Cardiopulmonary AG | 2015-10-24 |
| 00699753450110 | Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-01 |
| 00699753450158 | Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-01 |
| 00699753450141 | Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-01 |
| 00699753450134 | Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-01 |
| 00699753450127 | Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-01 |
| 00699753450103 | Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-01 |
| 00699753450097 | Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-01 |
| 00699753450073 | Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-01 |
| 00699753450059 | Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-01 |
| 00699753450035 | Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | 2015-10-01 |
| 08033178109550 | BMR | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178250375 | CARDIOTOMY RESERVOIR | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178250221 | RESERVOIR | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178250160 | RESERVOIR | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178109673 | CARDIOTOMY RESERVOIR | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 00673978537184 | Intersept® | MEDTRONIC, INC. | 2015-06-09 |
| 00613994269782 | Minimax® | MEDTRONIC, INC. | 2015-06-09 |