510(k) K160961 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Mozec NC-Rx PTCA Baloon Dilatation Catheter
| Applicant | Meril Life Sciences Private Limited, Vapi, IN |
| Decision | Substantially Equivalent, Jul 30, 2016 |
| Received | Apr 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160961
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.