510(k) K200700 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
| Applicant | Creagh Medical, Ltd., Ballinasloe, IE |
| Decision | Substantially Equivalent, May 14, 2020 |
| Received | Mar 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200700
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.