Filter, Prebypass, Cardiopulmonary Bypass
FDA product code KRJ · Class II (moderate risk) · 21 CFR 870.4280 · Cardiovascular
24510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Medtronic Blood Systems, Inc. 4
- Medical, Inc. 3
- Pall Biomedical Products Co. 3
- Delta Medical Industries 2
- Bentley Laboratories, Inc. 2
- American Omni Medical, Inc. 2
- Porous Media Corp. 2
- Texas Medical Products, Inc. 1
- Gelman Sciences, Inc. 1
- Gish Biomedical, Inc. 1
- Shiley, Inc. 1
- Rapid Diagnostic Laboratories, Inc. 1
- Avecor Cardiovascular, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990276 | Porous Media DPB30 Series Disposable Pre-Bypass FilterKRJ · Traditional | Porous Media Corp. | 10/01/1999SE |
| K982385 | Porous Media DPB20 Series Disposable Pre-Bypass FilterKRJ · Traditional | Porous Media Corp. | 02/01/1999SE |
| K940126 | Avecor Pre-Bypass FilterKRJ · Traditional | Avecor Cardiovascular, Inc. | 06/28/1994SE |
| K900672 | Prebypass Filter, Cat. No. FPB-5KRJ · Traditional | American Omni Medical, Inc. | 04/03/1990SE |
| K885154 | Intersept* Crystalloid Cardioplegia Deliv. SystemKRJ · Traditional | Medtronic Blood Systems, Inc. | 02/22/1989SE |
| K884390 | Intersept* Crystalloid Cardioplegia FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 12/21/1988SE |
| K884244 | Intersept* Prebypass FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 12/05/1988SE |
| K883086 | Intersept*Prebypass FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 09/16/1988SE |
| K875094 | Ultipor Pre-Bypass Plus Filter W/Posidyne MembraneKRJ · Traditional | Pall Biomedical Products Co. | 02/29/1988SE |
| K871350 | Prebypass FilterKRJ · Traditional | American Omni Medical, Inc. | 06/08/1987SE |
| K861226 | Interface Crystalloid Cardioplegic Filter Model 70KRJ · Traditional | Medical, Inc. | 06/02/1986SE |
| K850139 | Cobe Cop Filter Cardiopulmonary Prebypass FilterKRJ · Traditional | Rapid Diagnostic Laboratories, Inc. | 04/10/1985SE |
| K842141 | Solution Clarification UnitKRJ · Traditional | Pall Biomedical Products Co. | 08/03/1984SE |
| K840450 | Shiley Prebypass FilterKRJ · Traditional | Shiley, Inc. | 04/17/1984SE |
| K832594 | Pre-Bypass Filter #Ec-Pbf SeriesKRJ · Traditional | Gish Biomedical, Inc. | 09/20/1983SE |
| K831286 | Ultipore Prebypass Plus FilterKRJ · Traditional | Pall Biomedical Products Co. | 06/08/1983SE |
| K812539 | Pre-Bypass FilterKRJ · Traditional | Gelman Sciences, Inc. | 10/13/1981SE |
| K812244 | Interface Pre Bypass Prime Filter #90KRJ · Traditional | Medical, Inc. | 08/25/1981SE |
| K812240 | Interface Pre Bypass Prime FilterKRJ · Traditional | Medical, Inc. | 08/25/1981SE |
| K810395 | Pre-Bypass FilterKRJ · Traditional | Texas Medical Products, Inc. | 03/05/1981SE |
| K803101 | Prebypass Filter CAT.#K-5KRJ · Traditional | Delta Medical Industries | 12/22/1980SE |
| K800135 | Cardioplegia Administration System CasKRJ · Traditional | Bentley Laboratories, Inc. | 02/01/1980SE |
| K790361 | Recirculation Filter Model RF-10KRJ · Traditional | Bentley Laboratories, Inc. | 03/28/1979SE |
| K780485 | Prebypass FilterKRJ · Traditional | Delta Medical Industries | 04/05/1978SE |