510(k) K082854 ยท DQY Catheter, Percutaneous
NANOCORSS .014 OTW PTA DILATATION CATHETER
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Dec 4, 2008 |
| Received | Sep 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082854
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2010 | Ev3, Inc. ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14W020120150, AB14W030 Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.