K240859
- 510(k) number
- K240859
- Device name
- Glidewire GT-R
- Applicant
- Terumo Corporation JP
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2024-08-21
- Date received
- 2024-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240859.pdf
Official FDA record: K240859
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.