510(k) K250225 ยท PPN Percutaneous Catheter, Ultrasound
Bolt Intravascular Lithotripsy (IVL) System
| Applicant | Bolt Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 25, 2025 |
| Received | Jan 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250225
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.