Defoamer, Cardiopulmonary Bypass
FDA product code DTP · Class II (moderate risk) · 21 CFR 870.4230 · Cardiovascular
34510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Shiley, Inc. 4
- Scimed Life Systems, Inc. 4
- Medtronic Vascular 4
- Gish Biomedical, Inc. 3
- C.R. Bard, Inc. 3
- American Bentley 2
- Cobe Cardiovascular, Inc. 2
- 3M Health Care, Sarns 2
- Medtronic Perfusion Systems 1
- Travenol Laboratories, S.A. 1
- Mapquet Cardiopulmonary AG 1
- Dideco S.P.A. 1
- 3M Health Care, Ltd. 1
- Cobe Laboratories, Inc. 1
- Cardio Metrics, Inc. 1
- Electromedics, Inc. 1
- Electromics, Inc. 1
- Terumo Medical Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101186 | Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding BagDTP · Traditional | Medtronic Perfusion Systems | 09/03/2010SE |
| K082412 | Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model Be-Vbt…DTP · Traditional | Mapquet Cardiopulmonary AG | 11/10/2008SE |
| K004046 | Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered…DTP · Traditional | Cobe Cardiovascular, Inc. | 04/26/2001SE |
| K002591 | Cobe Smarxt VVR 4000 Filtered Hardshell Venous ReservoirDTP · Special | Cobe Cardiovascular, Inc. | 09/13/2000SE |
| K990514 | Modification of Bard Quantum CVR, Model H-6770VRDTP · Special | C.R. Bard, Inc. | 03/09/1999SE |
| K984322 | Dideco D920, Lilliput 1 Twin ReservoirDTP · Traditional | Dideco S.P.A. | 03/02/1999SE |
| K962726 | Bard Quantum CVRDTP · Traditional | C.R. Bard, Inc. | 10/30/1996SE |
| K941654 | Sarns Filtered Venous Reservior ModificationDTP · Traditional | 3M Health Care, Sarns | 07/26/1994SE |
| K933496 | Maxima Filtered Hardshell ReserviorDTP · Traditional | Medtronic Vascular | 10/15/1993SE |
| K912915 | Sarns Non-Filtered Venous ReservoirDTP · Traditional | 3M Health Care, Ltd. | 09/25/1991SE |
| K911789 | Minimax (TM) Hardshell Venous Res W/Inte Card FiltDTP · Traditional | Medtronic Vascular | 08/20/1991SE |
| K910568 | Model 5866-46 Sleeve KitDTP · Traditional | Medtronic Vascular | 04/09/1991SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | Cobe Laboratories, Inc. | 12/17/1990SE |
| K902856 | Bard Filtered Cardiotomy ReservoirDTP · Traditional | C.R. Bard, Inc. | 09/27/1990SE |
| K902355 | MCR4000 & MCR4000F Cardiotomy ReservoirDTP · Traditional | Medtronic Vascular | 08/23/1990SE |
| K874924 | CAP-35 and CAP35 FDTP · Traditional | Gish Biomedical, Inc. | 01/19/1988SE |
| K872167 | Cardiotomy/Mediastinal Auto. Reservoir CATR-3500DTP · Traditional | American Bentley | 09/01/1987SE |
| K870792 | Thorastat Atr-XxxxDTP · Traditional | Gish Biomedical, Inc. | 04/28/1987SE |
| K860775 | Mediastinal Autotransfusion SystemDTP · Traditional | Cardio Metrics, Inc. | 05/28/1986SE |
| K860702 | Sarns Filtered Cardiotomy ReservoirDTP · Traditional | 3M Health Care, Sarns | 05/28/1986SE |
| K855049 | Modified Model SC4000(F) Cardiotomy ReservoirDTP · Traditional | Scimed Life Systems, Inc. | 02/26/1986SE |
| K853503 | Shiley 3L Cardiotomy ReservoirDTP · Traditional | Shiley, Inc. | 11/14/1985SE |
| K851004 | Cardiotomy Reservoir Brs-Xxx & Holder Brs-HxxDTP · Traditional | Gish Biomedical, Inc. | 05/16/1985SE |
| K844803 | Polyester Cardiotomy Reservoir, Filtered & UnfilteDTP · Traditional | Electromedics, Inc. | 04/29/1985SE |
| K842373 | Venous RESERVOIR-BMR-1500-HARD ShellDTP · Traditional | American Bentley | 12/27/1984SE |
| K840610 | Scimed Model SC4000DTP · Traditional | Scimed Life Systems, Inc. | 04/24/1984SE |
| K834041 | Cardiotomy Reservoir SC3500FDTP · Traditional | Scimed Life Systems, Inc. | 01/30/1984SE |
| K832811 | Shiley 3L Cardf PlusDTP · Traditional | Shiley, Inc. | 09/20/1983SE |
| K830727 | Cardiotomy Reservoir-Filtered & NonDTP · Traditional | Electromics, Inc. | 04/05/1983SE |
| K823731 | CardfDTP · Traditional | Shiley, Inc. | 01/05/1983SE |
| K821538 | Capiox Cr-Cardiotomy ReservoirDTP · Traditional | Terumo Medical Corp. | 08/06/1982SE |
| K820954 | Scimed Model SC 3000DTP · Traditional | Scimed Life Systems, Inc. | 05/24/1982SE |
| K801375 | Shiley Cardiotomy Reservoir W/FilterDTP · Traditional | Shiley, Inc. | 07/14/1980SE |
| K801360 | Cardiotomy Reservoir with FilterDTP · Traditional | Travenol Laboratories, S.A. | 07/14/1980SE |