FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
FDA 510(k) clearance K240460 · decided 2024-06-13
Clearance details
- K-number
- K240460
- Device name
- FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
- Applicant
- FMD Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-16
- Decision date
- 2024-06-13
- Days to decision
- 118 days
- Clearance type
- Special
- 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.