510(k) K242419 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
| Applicant | Creagh Medical Ltd. Dba Surmodics, Inc., Ballinasloe, IE |
| Decision | Substantially Equivalent, Nov 15, 2024 |
| Received | Aug 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242419
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.