510(k) K161803 ยท MOF Guide, Wire, Catheter, Neurovasculature
Traxcess .007 Mini Guidewire
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Sep 30, 2016 |
| Received | Jun 30, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2017 | Microvention, Inc. MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX. Terminated |
MOF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.