510(k) K143561 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
ELM PTA Balloon Dilatation Catheter
| Applicant | O'Connell Regulatory Consultants, Inc., North Reading MA, US |
| Decision | Substantially Equivalent, May 19, 2015 |
| Received | Dec 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143561
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.