510(k) K161384 ยท PPN Percutaneous Catheter, Ultrasound
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
| Applicant | Shockwave Medical, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Sep 14, 2016 |
| Received | May 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161384
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.