# K780126: Dilator, Vessel & Introducer, Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Corp.
- Decided: Mar 2, 1978 after 37 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961745: Braun Percutaneous Introducer Set (1996), 0 descendants of its own

## Recalls of this device
- Jun 1, 2026 · Class I · Z-2705-2026: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Jun 19, 2020 · Class II · Z-2806-2020: Sterile introducer sheath set manufactured under one lot with different expiration dates.
- Apr 8, 2020 · Class II · Z-1938-2020: Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to 
- Feb 17, 2016 · Class II · Z-1029-2016: The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.
- Jan 6, 2009 · Not classified · Z-0764-2010: One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.

Source page: https://510kreport.com/device/K780126
Methodology: https://510kreport.com/methodology