K253746
- 510(k) number
- K253746
- Device name
- Enroute 0.014'' Transcarotid Guidewire
- Applicant
- Lake Region Medical IE
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2026-03-19
- Date received
- 2025-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253746.pdf
Official FDA record: K253746
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.