510(k) K260816 ยท OBJ Catheter, Ultrasound, Intravascular
OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imag
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Apr 8, 2026 |
| Received | Mar 13, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260816
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.