# K113849: HQS Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Alseal
- Decided: Jul 31, 2012 after 215 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 K032073 (2003). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093791: Gore Dryseal Sheath, W. L. Gore & Associates, Inc. (2010) Summary page 1.

## Most influential descendants
- K133296: XCATH (2014), 0 descendants of its own

## Indications for use
The HQS introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions

Source page: https://510kreport.com/device/K113849
Methodology: https://510kreport.com/methodology