510(k) K160173 ยท DXK Echocardiograph
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
| Applicant | Boston Scientific Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Feb 26, 2016 |
| Received | Jan 27, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160173
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.