510(k) K262201 ยท PPN Percutaneous Catheter, Ultrasound
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter
| Applicant | Shockwave Medical, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jul 27, 2026 |
| Received | Jun 29, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K262201
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.