510(k) K213593 ยท OBJ Catheter, Ultrasound, Intravascular
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jan 14, 2022 |
| Received | Nov 12, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213593
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2024 | Boston Scientific Corporation OptiCross Coronary Imaging Catheter, REF H749518080120 Open, Classified |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.