K240460 is an FDA 510(k) clearance for the FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259). 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 June 13, 2024, 118 days after receiving the submission on February 16, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K240460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2024 |
| Decision Date | June 13, 2024 |
| Days to Decision | 118 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 |