510(k) K153069 ยท OMZ Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Edwards Balloon Catheter
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 7, 2016 |
| Received | Oct 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153069
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.