510(k) K170941 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
RX NC Takeru PTCA Balloon Dilatation Catheter
| Applicant | KANEKA Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Jul 7, 2017 |
| Received | Mar 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170941
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.