510(k) K143587 ยท DQX Wire, Guide, Catheter
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jan 15, 2015 |
| Received | Dec 18, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K143587
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2016 | Boston Scientific Corporation Boston Scientific, PT Graphix Magnet J-TIP Guidewire
with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) .
Boston Scientifi Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.