510(k) K180958 ยท PPN Percutaneous Catheter, Ultrasound
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
| Applicant | Shockwave Medical, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Jul 26, 2018 |
| Received | Apr 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180958
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.