510(k) K152080 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Metacross OTW PTA Balloon Dilatation Catheter
| Applicant | KANEKA Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Sep 24, 2015 |
| Received | Jul 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152080
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.