510(k) K180454 ยท PPN Percutaneous Catheter, Ultrasound
Shockwave Medical Intravascular Lithotripsy (IVL) System
| Applicant | Shockwave Medical, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Jun 27, 2018 |
| Received | Feb 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180454
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2018 | Shockwave Medical, Inc. The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femor Terminated |
PPN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.