The following data is part of a premarket notification filed by Fmd Co., Ltd. with the FDA for Fmd Peripheral Guide Wires F-14 And F-18, Fmd Guide Wire Extension F-14 Ext.
| Device ID | K212268 |
| 510k Number | K212268 |
| Device Name: | FMD Peripheral Guide Wires F-14 And F-18, FMD Guide Wire Extension F-14 EXT |
| Classification | Wire, Guide, Catheter |
| Applicant | FMD Co., Ltd. 1-57-7 Sasazuka Shibuya-ku, JP 151-0073 |
| Contact | Takashi Higashikubo |
| Correspondent | Maximilian Bynum FMD Co., Ltd. 2777 Yulupa Ave. Ste 303 Santa Rosa, CA 95405 -8584 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2022-05-27 |