# K071330: Galtstick Introducer System

- Pathway: 510(k) (Special)
- Applicant: Galt Medical Corp.
- Decided: Oct 31, 2007 after 173 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000737 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000737: Coaxial Dilator Set, Xentek Medical, Inc. (2000) Summary page 4.

## Most influential descendants
- K161336: VSI StraitSet micro-introducer kit (2016), 0 descendants of its own

## Indications for use
The Galtstick™ Introduce system is indicated for percutaneous introduction and place of catheters and guidewires.

Source page: https://510kreport.com/device/K071330
Methodology: https://510kreport.com/methodology