510(k) K071554 ยท OBJ Catheter, Ultrasound, Intravascular
VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM
| Applicant | Volcano Corporation, Rancho Cordova, CA, US |
| Decision | Substantially Equivalent, Jan 4, 2008 |
| Received | Jun 7, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071554
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2017 | Volcano Corporation Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07 Terminated |
OBJ | None listed |
| Apr 25, 2016 | Volcano Corporation Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits.
Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qua Terminated |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.