510(k) K111706 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
| Applicant | Volcano Corporation, Rancho Cordova, CA, US |
| Decision | Substantially Equivalent, Jul 15, 2011 |
| Received | Jun 17, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111706
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2012 | Volcano Corporation Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and dist Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.