510(k) K121273 ยท OBJ Catheter, Ultrasound, Intravascular
VISIONS PV .035 DITITAL IVUS CATHETER
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Sep 10, 2012 |
| Received | Apr 27, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K121273
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2022 | Volcano Corp Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797 Open, Classified |
OBJ | None listed |
| Oct 17, 2018 | Volcano Corporation Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173
Product Usage:
The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultra Terminated |
OBJ | None listed |
| Jun 25, 2015 | Volcano Corporation Volcano PV .035 Catheter:
Part number: 88901;
Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by provi Terminated |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.