510(k) K093286 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
POWERCROSS .018 OTW PTA DILATION CATHETER
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 13, 2009 |
| Received | Oct 20, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2016 | Medtronic Inc ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO.
The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapoplit Terminated |
LIT | None listed |
| Apr 22, 2016 | ev3, Inc. ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only. Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.