510(k) K080891 ยท OBJ Catheter, Ultrasound, Intravascular
REVOLUTION 45MHZ IVUS IMAGING CATHETER
| Applicant | Volcano Corporation, Rancho Cordova, CA, US |
| Decision | Substantially Equivalent, May 12, 2008 |
| Received | Mar 31, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080891
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.