# K123430: Microslider Tearaway Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Galt Medical Corp.
- Decided: Apr 12, 2013 after 156 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 K000313 (2000). 6 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000313: Tearaway Introducer Sheath, Xentek Medical, Inc. (2000) Summary page 1.
- K112398: Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side Port, Galt Medical (2012) Summary page 1.
- K121504: Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets, Togo Medikit Co., Ltd. (2012) Summary page 3.

## Most influential descendants
- K153533: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (2016), 4 descendants of its own
- K170020: Peel-Away Introducer Set (2017), 1 descendant of its own
- K261950: Health Line Tearaway Introducer (2026), 0 descendants of its own
- K254236: Peel-Away Introducer Sheath (2026), 0 descendants of its own
- K173685: Peel-Away Introducer Set (2017), 0 descendants of its own

## Indications for use
The Introducer System is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages

Source page: https://510kreport.com/device/K123430
Methodology: https://510kreport.com/methodology