K895427 is an FDA 510(k) clearance for the MEDISEAL SUCTION CANISTER. This device is classified as a Suction Control, Intracardiac, Cardiopulmonary Bypass (Class II - Special Controls, product code DWD).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on January 19, 1990, 136 days after receiving the submission on September 5, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4430.
| 510(k) Number | K895427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1989 |
| Decision Date | January 19, 1990 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DWD — Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4430 |