510(k) K113486 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM
| Applicant | Volcano Corporation, Rancho Cordova, CA, US |
| Decision | Substantially Equivalent, Jan 27, 2012 |
| Received | Nov 23, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113486
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.