K874405 is an FDA 510(k) clearance for the PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE. This device is classified as a Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass (Class II - Special Controls, product code JOD).
Submitted by Pall Biomedical Products Co. (Glen Cove, US). The FDA issued a Cleared decision on December 30, 1987, 63 days after receiving the submission on October 28, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4270.
| 510(k) Number | K874405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1987 |
| Decision Date | December 30, 1987 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | JOD — Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4270 |