510(k) K103322 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
EVERCROSS 0.035 OTW PTA DILATION CATHETER
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Dec 6, 2010 |
| Received | Nov 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103322
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2014 | Ev3, Inc. ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Periphera Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.