K880052 is an FDA 510(k) clearance for the EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR. This device is classified as a Holder, Heart-valve, Prosthesis (Class I - General Controls, product code DTJ).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on April 1, 1988, 86 days after receiving the submission on January 6, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3935.
| 510(k) Number | K880052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1988 |
| Decision Date | April 01, 1988 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTJ — Holder, Heart-valve, Prosthesis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.3935 |