# K153533: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Galt Medical Corp.
- Decided: Jul 5, 2016 after 209 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000313 (2000). 7 ancestors in all.
4 later devices descend from it; 3 cite 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 4.
- K123430: Microslider Tearaway Introducer Set, Galt Medical Corp. (2013) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- May 8, 2023 · Class II · Z-1969-2023: Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator com
- May 8, 2023 · Class II · Z-1968-2023: Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator com

## Indications for use
Tearaway introducer sheath: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads, into the vasculature. MicroSlide™ Tearaway introducer: These introducers are used for the 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/K153533
Methodology: https://510kreport.com/methodology