510(k) K092303 ยท DQX Wire, Guide, Catheter
MERIT LAUREATE HYDROPHILIC GUIDE WIRE
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Oct 27, 2009 |
| Received | Jul 29, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092303
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2010 | Merit Medical Systems, Inc. Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095.
Intended to facilitate the placement of de Terminated |
DQX | None listed |
| Jun 28, 2010 | Merit Medical Systems, Inc. Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095.
Intended to facilitate the pla Terminated |
DQX | None listed |
| Jun 28, 2010 | Merit Medical Systems, Inc. Merit Laureate Hydrophylic Guide Wire, Straight, Made In Ireland, CAT No: LWSTFS35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095.
Intended to facilitate the placement of Terminated |
DQX | None listed |
| Jun 28, 2010 | Merit Medical Systems, Inc. Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095.
Intended to facilitate the placement of Terminated |
DQX | None listed |
| Jun 28, 2010 | Merit Medical Systems, Inc. Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095.
Intended to facilitate the p Terminated |
DQX | None listed |
| Jun 28, 2010 | Merit Medical Systems, Inc. Merit Laureate Hydrophylic Guide Wire, Straight Stiff Shaft, Made in Ireland, CAT No: LWSTFS35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095.
Intended to facilitate the Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.