Product code KRJ
- Device name
- Filter, Prebypass, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4280
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- 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 |
|---|---|---|---|
| K990276 | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | 1999-10-01 |
| K982385 | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | 1999-02-01 |
| K940126 | AVECOR PRE-BYPASS FILTER | Avecor Cardiovascular, Inc. | 1994-06-28 |
| K900672 | PREBYPASS FILTER, CAT. NO. FPB-5 | American Omni Medical, Inc. | 1990-04-03 |
| K885154 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | Medtronic Blood Systems, Inc. | 1989-02-22 |
| K884390 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | Medtronic Blood Systems, Inc. | 1988-12-21 |
| K884244 | INTERSEPT* PREBYPASS FILTER | Medtronic Blood Systems, Inc. | 1988-12-05 |
| K883086 | INTERSEPT*PREBYPASS FILTER | Medtronic Blood Systems, Inc. | 1988-09-16 |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | 1988-02-29 |
| K871350 | PREBYPASS FILTER | American Omni Medical, Inc. | 1987-06-08 |
| K861226 | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | Medical, Inc. | 1986-06-02 |
| K850139 | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | Rapid Diagnostic Laboratories, Inc. | 1985-04-10 |
| K842141 | SOLUTION CLARIFICATION UNIT | Pall Biomedical Products Co. | 1984-08-03 |
| K840450 | SHILEY PREBYPASS FILTER | Shiley, Inc. | 1984-04-17 |
| K832594 | PRE-BYPASS FILTER #EC-PBF SERIES | Gish Biomedical, Inc. | 1983-09-20 |
| K831286 | ULTIPORE PREBYPASS PLUS FILTER | Pall Biomedical Products Co. | 1983-06-08 |
| K812539 | PRE-BYPASS FILTER | Gelman Sciences, Inc. | 1981-10-13 |
| K812244 | INTERFACE PRE BYPASS PRIME FILTER #90 | Medical, Inc. | 1981-08-25 |
| K812240 | INTERFACE PRE BYPASS PRIME FILTER | Medical, Inc. | 1981-08-25 |
| K810395 | PRE-BYPASS FILTER | Texas Medical Products, Inc. | 1981-03-05 |
| K803101 | PREBYPASS FILTER CAT.#K-5 | Delta Medical Industries | 1980-12-22 |
| K800135 | CARDIOPLEGIA ADMINISTRATION SYSTEM CAS | Bentley Laboratories, Inc. | 1980-02-01 |
| K790361 | RECIRCULATION FILTER MODEL RF-10 | Bentley Laboratories, Inc. | 1979-03-28 |
| K780485 | PREBYPASS FILTER | Delta Medical Industries | 1978-04-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B462DPC2022S500C5 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2026-01-12 |
| B462DPB3033PES002YV3 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2023-01-20 |
| B4624150002215 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2021-03-26 |
| B4624150002200 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2021-03-26 |
| B4624150002210 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2021-03-26 |
| B4624150002205 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2021-03-26 |
| B462DPB3033PES002YN3 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2020-12-07 |
| B462DPB3033PES002YN0 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2020-12-07 |
| B4620008810893 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2018-11-07 |
| B4620170169013 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2018-01-04 |
| B4620302183 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B4624724230000013 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B46210210393 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B46210210403 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B46210310843 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B46210310863 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B4623452600003 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B4623452700003 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B4623452800003 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B4623452900005 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B4620170169025 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B4620170169005 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B4620008038383 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B4620008038123 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B4620008012125 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B46200080020335 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B46200080020235 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B46200080020225 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B46200080020125 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |
| B46200080020115 | Pentair | PENTAIR FILTRATION SOLUTIONS, LLC | 2017-12-31 |