K252315
- 510(k) number
- K252315
- Device name
- Santreva-ATK Endovascular Revasculariztion Catheter
- Applicant
- AngioSafe, Inc. CA · US
- Product code
- PDU — Catheter For Crossing Total Occlusions
- Decision date
- 2025-09-22
- Date received
- 2025-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252315.pdf
Official FDA record: K252315
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.