510(k) K111395 ยท DQX Wire, Guide, Catheter
PRIMEWIRE PRESTIGE PLUS
| Applicant | Volcano Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Aug 1, 2011 |
| Received | May 19, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2015 | Volcano Corporation Prestige Plus 185cm J-Tip:
Part number: 9185J;
Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.