KRJ — Filter, Prebypass, Cardiopulmonary Bypass Class II
FDA product code KRJ covers "Filter, Prebypass, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4280. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRJ
- Device Class
- Class II
- Regulation Number
- 870.4280
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K990276 | porous media | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | October 1, 1999 |
| K982385 | porous media | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | February 1, 1999 |
| K940126 | avecor cardiovascular | AVECOR PRE-BYPASS FILTER | June 28, 1994 |
| K900672 | american omni medical | PREBYPASS FILTER, CAT. NO. FPB-5 | April 3, 1990 |
| K885154 | medtronic blood systems | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | February 22, 1989 |
| K884390 | medtronic blood systems | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | December 21, 1988 |
| K884244 | medtronic blood systems | INTERSEPT* PREBYPASS FILTER | December 5, 1988 |
| K883086 | medtronic blood systems | INTERSEPT*PREBYPASS FILTER | September 16, 1988 |
| K875094 | pall biomedical products | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | February 29, 1988 |
| K871350 | american omni medical | PREBYPASS FILTER | June 8, 1987 |
| K861226 | medical | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | June 2, 1986 |
| K850139 | rapid diagnostic laboratories | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | April 10, 1985 |
| K842141 | pall biomedical products | SOLUTION CLARIFICATION UNIT | August 3, 1984 |
| K840450 | shiley | SHILEY PREBYPASS FILTER | April 17, 1984 |
| K832594 | gish biomedical | PRE-BYPASS FILTER #EC-PBF SERIES | September 20, 1983 |
| K831286 | pall biomedical products | ULTIPORE PREBYPASS PLUS FILTER | June 8, 1983 |
| K812539 | gelman sciences | PRE-BYPASS FILTER | October 13, 1981 |
| K812244 | medical | INTERFACE PRE BYPASS PRIME FILTER #90 | August 25, 1981 |
| K812240 | medical | INTERFACE PRE BYPASS PRIME FILTER | August 25, 1981 |
| K810395 | texas medical products | PRE-BYPASS FILTER | March 5, 1981 |