510(k) K173820 ยท OBJ Catheter, Ultrasound, Intravascular
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)
| Applicant | Boston Scientific Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Jan 17, 2018 |
| Received | Dec 18, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173820
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.