K254006
- 510(k) number
- K254006
- Device name
- Drivewire 35 Guidewire
- Applicant
- Rapid Medical Ltd. IL
- Product code
- MOF — Guide, Wire, Catheter, Neurovasculature
- Decision date
- 2026-07-17
- Date received
- 2025-12-15
- 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: K254006.pdf
Official FDA record: K254006
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.