K911789 is an FDA 510(k) clearance for the MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT. 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 20, 1991, 120 days after receiving the submission on April 22, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4230.
| 510(k) Number | K911789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1991 |
| Decision Date | August 20, 1991 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DTP — Defoamer, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4230 |