510(k) K130766 ยท DQX Wire, Guide, Catheter
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Jul 17, 2013 |
| Received | Mar 20, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130766
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2016 | Cook Inc. Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-3 Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.