FDA Product Code
FDA Product Code KRJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4280
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K990276 | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | 1999-10-01 | Traditional | PDF ↗ |
| K982385 | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | 1999-02-01 | Traditional | PDF ↗ |
| K940126 | AVECOR PRE-BYPASS FILTER | Avecor Cardiovascular, Inc. | 1994-06-28 | Traditional | PDF ↗ |
| K900672 | PREBYPASS FILTER, CAT. NO. FPB-5 | American Omni Medical, Inc. | 1990-04-03 | Traditional | PDF ↗ |
| K885154 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | Medtronic Blood Systems, Inc. | 1989-02-22 | Traditional | PDF ↗ |
| K884390 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | Medtronic Blood Systems, Inc. | 1988-12-21 | Traditional | PDF ↗ |
| K884244 | INTERSEPT* PREBYPASS FILTER | Medtronic Blood Systems, Inc. | 1988-12-05 | Traditional | PDF ↗ |
| K883086 | INTERSEPT*PREBYPASS FILTER | Medtronic Blood Systems, Inc. | 1988-09-16 | Traditional | PDF ↗ |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | 1988-02-29 | Traditional | PDF ↗ |
| K871350 | PREBYPASS FILTER | American Omni Medical, Inc. | 1987-06-08 | Traditional | PDF ↗ |
| K861226 | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | Medical, Inc. | 1986-06-02 | Traditional | PDF ↗ |
| K850139 | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | Rapid Diagnostic Laboratories, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K842141 | SOLUTION CLARIFICATION UNIT | Pall Biomedical Products Co. | 1984-08-03 | Traditional | PDF ↗ |
| K840450 | SHILEY PREBYPASS FILTER | Shiley, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K832594 | PRE-BYPASS FILTER #EC-PBF SERIES | Gish Biomedical, Inc. | 1983-09-20 | Traditional | PDF ↗ |
| K831286 | ULTIPORE PREBYPASS PLUS FILTER | Pall Biomedical Products Co. | 1983-06-08 | Traditional | PDF ↗ |
| K812539 | PRE-BYPASS FILTER | Gelman Sciences, Inc. | 1981-10-13 | Traditional | PDF ↗ |
| K812240 | INTERFACE PRE BYPASS PRIME FILTER | Medical, Inc. | 1981-08-25 | Traditional | PDF ↗ |
| K812244 | INTERFACE PRE BYPASS PRIME FILTER #90 | Medical, Inc. | 1981-08-25 | Traditional | PDF ↗ |
| K810395 | PRE-BYPASS FILTER | Texas Medical Products, Inc. | 1981-03-05 | Traditional | PDF ↗ |
| K803101 | PREBYPASS FILTER CAT.#K-5 | Delta Medical Industries | 1980-12-22 | Traditional | PDF ↗ |
| K800135 | CARDIOPLEGIA ADMINISTRATION SYSTEM CAS | Bentley Laboratories, Inc. | 1980-02-01 | Traditional | PDF ↗ |
| K790361 | RECIRCULATION FILTER MODEL RF-10 | Bentley Laboratories, Inc. | 1979-03-28 | Traditional | PDF ↗ |
| K780485 | PREBYPASS FILTER | Delta Medical Industries | 1978-04-05 | Traditional | PDF ↗ |
Product code KRJ · Class II · Cardiovascular. Data: openFDA.