510(k) K160985 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Pantera Pro
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Oct 7, 2016 |
| Received | Apr 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160985
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.