# K091367: GDS-DCS

- Pathway: 510(k) (Traditional)
- Applicant: Guided Delivery Systems
- Decided: Nov 5, 2009 after 181 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: 4 generations back to K964518 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072719: Convoy Advanced Delivery Sheath, Boston Scientific Corp (2008) Summary page 1.
- K000659: Modification to Softouch Diagnostic Intravascular Cat, Merit Medical Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K100135: GDS-DC12 (2010), 0 descendants of its own

## Indications for use
GDS-DC6 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.

Source page: https://510kreport.com/device/K091367
Methodology: https://510kreport.com/methodology