510(k) K173581 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Gallant PTCA Dilatation Catheter
| Applicant | Medinol, Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Jan 25, 2018 |
| Received | Nov 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173581
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.