K905500 is an FDA 510(k) clearance for the MYOCARDIAL PROTECTION SYSTEM. This device is classified as a Heat-exchanger, Cardiopulmonary Bypass (Class II - Special Controls, product code DTR).
Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on June 10, 1991, 185 days after receiving the submission on December 7, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4240.
| 510(k) Number | K905500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1990 |
| Decision Date | June 10, 1991 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTR — Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4240 |