510(k) K211044 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Sublime Radial Access 018 RX Dilatation Catheter
| Applicant | Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,, Ballinasloe, IE |
| Decision | Substantially Equivalent, Jun 16, 2021 |
| Received | Apr 8, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211044
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.