510(k) K123621 ยท OBJ Catheter, Ultrasound, Intravascular
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER
| Applicant | Boston Scientific Corp, Fremont CA, US |
| Decision | Substantially Equivalent, Apr 15, 2013 |
| Received | Nov 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123621
| 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.