510(k) K120644 ยท DQX Wire, Guide, Catheter
MERIT HYDROPHILIC GUIDE WIRE
| Applicant | Merit Medical Systems, Inc., Galway, IE |
| Decision | Substantially Equivalent, Sep 19, 2012 |
| Received | Mar 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120644
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2014 | Merit Medical Systems, Inc. Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102"). Terminated |
DQX | None listed |
| Apr 22, 2014 | Merit Medical Systems, Inc. Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102"). Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.