K844803 is an FDA 510(k) clearance for the POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE. This device is classified as a Defoamer, Cardiopulmonary Bypass (Class II - Special Controls, product code DTP).
Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on April 29, 1985, 139 days after receiving the submission on December 11, 1984.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4230.
| 510(k) Number | K844803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 1984 |
| Decision Date | April 29, 1985 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTP — Defoamer, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4230 |