K140042 is an FDA 510(k) clearance for the 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME. This device is classified as a Valvulotome (Class II - Special Controls, product code MGZ).
Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on April 10, 2014, 92 days after receiving the submission on January 8, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K140042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2014 |
| Decision Date | April 10, 2014 |
| Days to Decision | 92 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 |