K240818
- 510(k) number
- K240818
- Device name
- R2P Radifocus Glidewire Advantage
- Applicant
- Terumo Corporation JP
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2024-11-26
- Date received
- 2024-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240818.pdf
Official FDA record: K240818
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.