510(k) K230453 ยท OBJ Catheter, Ultrasound, Intravascular
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, May 18, 2023 |
| Received | Feb 21, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230453
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.