K260246
- 510(k) number
- K260246
- Device name
- SEISMIQ Intravascular Lithotripsy System
- Applicant
- Bolt Medical, Inc. CA · US
- Product code
- PPN — Percutaneous Catheter, Ultrasound
- Decision date
- 2026-08-24
- Date received
- 2026-01-27
- 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: K260246.pdf
Official FDA record: K260246
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.