# K142819: Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 24, 2015 after 298 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: 5 generations back to K924607 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091329: Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2009) Summary page 4.
- K984500: Cordis Brite Tip Catheter Sheath Introducer System, Cordis Corp. (1998) Summary page 4.

## Most influential descendants
- K153430: Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select (2016), 0 descendants of its own

## Indications for use
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Source page: https://510kreport.com/device/K142819
Methodology: https://510kreport.com/methodology