# K203670: Extra Large Check-Flo Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Feb 16, 2021 after 62 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: 3 generations back to K032073 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093791: Gore Dryseal Sheath, W. L. Gore & Associates, Inc. (2010) Summary page 4.

## Indications for use
Extra Large Check-Flo introducers and guiding sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature.

Source page: https://510kreport.com/device/K203670
Methodology: https://510kreport.com/methodology