K132190 is an FDA 510(k) clearance for the EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME. This device is classified as a Valvulotome (Class II - Special Controls, product code MGZ).
Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on August 5, 2013, 21 days after receiving the submission on July 15, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K132190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2013 |
| Decision Date | August 05, 2013 |
| Days to Decision | 21 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 |