FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
FDA 510(k) clearance K212268 · decided 2022-05-27
Clearance details
- K-number
- K212268
- Device name
- FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
- Applicant
- FMD Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-20
- Decision date
- 2022-05-27
- Days to decision
- 311 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shibuya-Ku, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.