K250225
- 510(k) number
- K250225
- Device name
- Bolt Intravascular Lithotripsy (IVL) System
- Applicant
- Bolt Medical, Inc. CA · US
- Product code
- PPN — Percutaneous Catheter, Ultrasound
- Decision date
- 2025-03-25
- Date received
- 2025-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K250225.pdf
Official FDA record: K250225
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.