# K152044: Flexor Radial Hydrophilic Introducer Access Set

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Aug 14, 2015 after 22 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 K954234 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132592: Flexor Radial Hydrophilic Introducer Access Set, Cook, Inc. (2014) Summary page 4.

## Most influential descendants
- K171609: Check-Flo Performer Introducer Micropuncture Radial Artery Access Set (2018), 0 descendants of its own

## Indications for use
The Flexor® Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

Source page: https://510kreport.com/device/K152044
Methodology: https://510kreport.com/methodology