510(k) K214038 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Oscar Peripheral Multifunctional Catheter system
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Jul 6, 2022 |
| Received | Dec 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214038
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.