K260544 is an FDA 510(k) clearance for the FMD Peripheral Guide Wire F-14 Flex 6. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by FMD Co., Ltd. (Shibuya-Ku, JP). The FDA issued a Cleared decision on March 20, 2026, 30 days after receiving the submission on February 18, 2026.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K260544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2026 |
| Decision Date | March 20, 2026 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |