510(k) K222065 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Passeo-35 Xeo Peripheral Dilatation Catheter
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Feb 16, 2023 |
| Received | Jul 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222065
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.