K250385
- 510(k) number
- K250385
- Device name
- Turbo-Elite Laser Atherectomy Catheter
- Applicant
- Spectranetics CO · US
- Product code
- MCW — Catheter, Peripheral, Atherectomy
- Decision date
- 2025-03-13
- Date received
- 2025-02-11
- 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: K250385.pdf
Official FDA record: K250385
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.