K190267 is an FDA 510(k) clearance for the EZE SIT Valvulotome. This device is classified as a Valvulotome (Class II - Special Controls, product code MGZ).
Submitted by Lemaitre Vascular (Burlington, US). The FDA issued a Cleared decision on October 30, 2019, 264 days after receiving the submission on February 8, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K190267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2019 |
| Decision Date | October 30, 2019 |
| Days to Decision | 264 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 |