K911790 is an FDA 510(k) clearance for the MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG. This device is classified as a Reservoir, Blood, Cardiopulmonary Bypass (Class II - Special Controls, product code DTN).
Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on August 12, 1991, 112 days after receiving the submission on April 22, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K911790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1991 |
| Decision Date | August 12, 1991 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |