KRJ — Filter, Prebypass, Cardiopulmonary Bypass Class II
FDA Device Classification
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 |
| K812240 | medical | INTERFACE PRE BYPASS PRIME FILTER | August 25, 1981 |
| K812244 | medical | INTERFACE PRE BYPASS PRIME FILTER #90 | August 25, 1981 |
| K810395 | texas medical products | PRE-BYPASS FILTER | March 5, 1981 |