510(k) K191840 ยท PPN Percutaneous Catheter, Ultrasound
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
| Applicant | Shockwave Medical, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Aug 7, 2019 |
| Received | Jul 9, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191840
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.