510(k) K884913 ยท DXT Injector And Syringe, Angiographic
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
| Applicant | Merit Medical Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Apr 18, 1989 |
| Received | Nov 28, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884913
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2024 | Merit Medical Systems, Inc. IntelliSystem Inflation Device, REF: IN1525/D Open, Classified |
DXT | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: MONARCH CATALOG NUMBER IN2130 for inflation and deflation of interventional devices Terminated |
DXT | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Monarch Inflation Syringe CATALOG NUMBER IN2230 for inflation and deflation of interventional devices Terminated |
DXT | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with filtered Sosa spike. Used to transfer contrast or saline into a sterile injector syringe Terminated |
DXT | None listed |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220 Terminated |
DXT | None listed |
| Nov 19, 2003 | Merit Medical Systems, Inc IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: ''INTELLISYSTEM 25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS PLUS LARGE BORE HEMOSTASIS VALVE, TORGUE DE Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.