510(k) K111723 ยท MCW Catheter, Peripheral, Atherectomy
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 27, 2011 |
| Received | Jun 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111723
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2018 | Micro Therapeutics Inc, Dba Ev3 Neurovascular ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use. Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.