510(k) K163660 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Pantera LEO
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Jan 26, 2017 |
| Received | Dec 27, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163660
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.