K221902 is an FDA 510(k) clearance for the LimFlow Vector. This device is classified as a Valvulotome (Class II - Special Controls, product code MGZ).
Submitted by LimFlow, Inc. (San Jose, US). The FDA issued a Cleared decision on December 21, 2022, 174 days after receiving the submission on June 30, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K221902 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2022 |
| Decision Date | December 21, 2022 |
| Days to Decision | 174 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 |