510(k) K172264 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
OTW Takeru PTCA Balloon Dilatation Catheter
| Applicant | KANEKA Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Mar 19, 2018 |
| Received | Jul 27, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172264
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.