K241553
- 510(k) number
- K241553
- Device name
- Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
- Applicant
- Eximo Medical, Ltd. IL
- Product code
- MCW — Catheter, Peripheral, Atherectomy
- Decision date
- 2024-06-27
- Date received
- 2024-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K241553.pdf
Official FDA record: K241553
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.