K933496 is an FDA 510(k) clearance for the MAXIMA FILTERED HARDSHELL RESERVIOR. 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 October 15, 1993, 88 days after receiving the submission on July 19, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4230.
| 510(k) Number | K933496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1993 |
| Decision Date | October 15, 1993 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTP — Defoamer, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4230 |