510(k) K021096 ยท MCW Catheter, Peripheral, Atherectomy
X-SIZER CATHETER SYSTEM
| Applicant | Ev3 Corporation, Plymouth MN, US |
| Decision | Substantially Equivalent, Sep 8, 2004 |
| Received | Apr 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021096
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2006 | Ev3, Inc X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution). Model number XR-CS1150-45 (for foreign distribution). 1.5mm. Sterilization with Ethylene Oxide Gas. ev3 Terminated |
MCW | None listed |
| Jun 14, 2006 | Ev3, Inc X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm. Sterilization with Ethylene Oxide Gas. ev3 Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.