510(k) K142379 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Passeo-35 PTA Catheter
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Dec 5, 2014 |
| Received | Aug 26, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142379
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.