K240460
- 510(k) number
- K240460
- Device name
- FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
- Applicant
- FMD Co., Ltd. JP
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2024-06-13
- Date received
- 2024-02-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K240460.pdf
Official FDA record: K240460
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.