510(k) K973334 ยท DXT Injector And Syringe, Angiographic
OZ POWER SYRINGE
| Applicant | Cardiovascular Innovations, Dallas TX, US |
| Decision | Substantially Equivalent, Apr 3, 1998 |
| Received | Sep 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973334
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2021 | LeMaitre Vascular, Inc. LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-0 Terminated |
DXT | None listed |
| Oct 4, 2007 | Lemaitre Vascular, Inc. CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC) Terminated |
DXT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.