# K230631: Kodiak™ Dual Port Coaxial Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices
- Decided: May 22, 2023 after 76 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: 1 generation back to K171999 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171999: Performer Introducer, Cook Incorporated (2017) Summary page 4.

## Indications for use
The Kodiak™ Dual Port Coaxial Introducer Kit is indicated to introduce therapeutic or diagnostic devices into the vasculature.

Source page: https://510kreport.com/device/K230631
Methodology: https://510kreport.com/methodology