510(k) K230191 · LIT Catheter, Angioplasty, Peripheral, Transluminal
Arise UHP Dilatation Catheter
| Applicant | Creagh Medical, Ltd., Ballinasloe, IE |
| Decision | Substantially Equivalent, Mar 22, 2023 |
| Received | Jan 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230191
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.