K212615 is an FDA 510(k) clearance for the EpiFaith CV. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Flat Medical Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on September 21, 2022, 399 days after receiving the submission on August 18, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K212615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2021 |
| Decision Date | September 21, 2022 |
| Days to Decision | 399 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX - Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |