510(k) K260246 · PPN Percutaneous Catheter, Ultrasound
SEISMIQ Intravascular Lithotripsy System
| Applicant | Bolt Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Aug 24, 2026 |
| Received | Jan 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260246
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.