510(k) K082229 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
| Applicant | Volcano Corporation, Rancho Cordova, CA, US |
| Decision | Substantially Equivalent, Oct 8, 2008 |
| Received | Aug 7, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082229
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2015 | Volcano Corp ComboMap Intravascular Flow and Pressure System;
Product/Part number: Combo Map - 802745-001.
Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular struct Terminated |
IYO | None listed |
| 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 |
| Nov 1, 2010 | Volcano Corporation Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA. Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.