K001734 is an FDA 510(k) clearance for the FOGARTY VALVULOTOME, MODEL 700091. This device is classified as a Valvulotome (Class II - Special Controls, product code MGZ).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on March 26, 2001, 292 days after receiving the submission on June 7, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K001734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2000 |
| Decision Date | March 26, 2001 |
| Days to Decision | 292 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MGZ — Valvulotome |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4885 |