# K140028: Galt Vti Low Insertion Valve Tearaway Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Galt Medical Corp.
- Decided: Aug 21, 2014 after 227 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112398: Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side Port, Galt Medical (2012) Summary page 4.

## Indications for use
The introducer system is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

Source page: https://510kreport.com/device/K140028
Methodology: https://510kreport.com/methodology