510(k) K153094 ยท OBJ Catheter, Ultrasound, Intravascular
Visions PV .035 Digital IVUS Catheter
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 31, 2015 |
| Received | Oct 26, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153094
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2022 | Volcano Corp Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , 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 81234/400-0200.272
Product Usage:
The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultra Terminated |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.