510(k) K011906 ยท DQX Wire, Guide, Catheter
BACK-UP MEIER GUIDEWIRE
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Aug 13, 2001 |
| Received | Jun 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011906
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2010 | Boston Scientific Corporation Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide.
The steerable guidewires are made of a stainless-steel, PTFE-coated proximal shaft, which tapers down to a ver Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.