510(k) K092299 ยท DQY Catheter, Percutaneous
TRAILBLAZER SUPPORT CATHETER
| Applicant | Ev3, Inc., Buffalo MN, US |
| Decision | Substantially Equivalent, Aug 7, 2009 |
| Received | Jul 29, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092299
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2009 | Ev3, Inc. TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO.
US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135,
SC-014-150, SC-018-150, Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.