510(k) K111043 ยท OBJ Catheter, Ultrasound, Intravascular
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
| Applicant | Boston Scientific Corp, Fremont CA, US |
| Decision | Substantially Equivalent, Aug 4, 2011 |
| Received | Apr 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111043
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.