K914385 is an FDA 510(k) clearance for the OPTICAL VALVULOTOME. This device is classified as a Valvulotome (Class II - Special Controls, product code MGZ).
Submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on March 2, 1992, 153 days after receiving the submission on October 1, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K914385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1991 |
| Decision Date | March 02, 1992 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MGZ — Valvulotome |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4885 |