K252317
- 510(k) number
- K252317
- Device name
- Zenith Micro Guidewire
- Applicant
- Suzhou Zenith Vascular SciTech Limited CN
- Product code
- MOF — Guide, Wire, Catheter, Neurovasculature
- Decision date
- 2026-04-16
- Date received
- 2025-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252317.pdf
Official FDA record: K252317
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.