510(k) K181023 · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter
| Applicant | Meril Life Sciences Private Limited, Vapi, IN |
| Decision | Substantially Equivalent, May 17, 2018 |
| Received | Apr 17, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181023
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.