K251376
- 510(k) number
- K251376
- Device name
- LimFlow ARC
- Applicant
- LimFlow, Inc. CA · US
- Product code
- PDU — Catheter For Crossing Total Occlusions
- Decision date
- 2025-05-31
- Date received
- 2025-05-02
- 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: K251376.pdf
Official FDA record: K251376
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.