510(k) K163372 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
RX Takeru Balloon Dilatation Catheter
| Applicant | KANEKA Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Apr 7, 2017 |
| Received | Dec 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163372
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.