510(k) K780126 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
DILATOR, VESSEL & INTRODUCER, SHEATH
| Applicant | Argon Medical Corp., Walker MI, US |
| Decision | Substantially Equivalent, Mar 2, 1978 |
| Received | Jan 24, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780126
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2026 | Argon Medical Devices, Inc One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular Open, Classified |
DRE | None listed |
| Jun 19, 2020 | Argon Medical Devices, Inc ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits bui Terminated |
DRE | None listed |
| Apr 8, 2020 | Argon Medical Devices, Inc PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percut Terminated |
GDY | None listed |
| Mar 1, 2016 | Argon Medical Devices, Inc ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11.
Indicated for use in arterial and venous procedures r Terminated |
DRE | None listed |
| Feb 2, 2010 | Argon Medical Devices, Inc Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA for VNUS, 5799 Fontan Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.