# K233432: 10F Sheath and Dilator Set

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices, Inc.
- Decided: Dec 8, 2023 after 57 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924607 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142829: Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer, Cook Incorporated (2015) Summary page 5.

## Indications for use
The 10F Sheath and Dilator Set is indicated for introduction of therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Source page: https://510kreport.com/device/K233432
Methodology: https://510kreport.com/methodology