510(k) K180007 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
| Applicant | Creagh Medical, Ltd., Ballinasloe, IE |
| Decision | Substantially Equivalent, Apr 19, 2018 |
| Received | Jan 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180007
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.