510(k) K133853 ยท OBJ Catheter, Ultrasound, Intravascular
VIEWFLEX XTRA ICE CATHETER
| Applicant | Irvine Biomedical, Inc., A St. Jude Medical Company, Irvine CA, US |
| Decision | Substantially Equivalent, May 19, 2014 |
| Received | Dec 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133853
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.