510(k) K151126 ยท DQO Catheter, Intravascular, Diagnostic
Foresight Intracardiac Echocardiography (ICE) System
| Applicant | Colibri Technologies, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Dec 18, 2015 |
| Received | Apr 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151126
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.