K902355 is an FDA 510(k) clearance for the MCR4000 & MCR4000F CARDIOTOMY RESERVOIR. This device is classified as a Defoamer, Cardiopulmonary Bypass (Class II - Special Controls, product code DTP).
Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on August 23, 1990, 86 days after receiving the submission on May 29, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4230.
| 510(k) Number | K902355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1990 |
| Decision Date | August 23, 1990 |
| Days to Decision | 86 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 |