K952879 is an FDA 510(k) clearance for the SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II - Special Controls, product code KFM).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on April 22, 1996, 304 days after receiving the submission on June 23, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4360.
| 510(k) Number | K952879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1995 |
| Decision Date | April 22, 1996 |
| Days to Decision | 304 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4360 |