510(k) K022634 ยท DYB Introducer, Catheter
CO-AXIAL INTRODUCER NEEDLE
| Applicant | Promex, Inc., Franklin IN, US |
| Decision | Substantially Equivalent, Nov 6, 2002 |
| Received | Aug 8, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022634
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Cat Terminated |
DYB | None listed |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, Terminated |
DYB | None listed |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO, Terminated |
DYB | None listed |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight ca Terminated |
DYB | None listed |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight ca Terminated |
DYB | None listed |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO, Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.