# K100135: GDS-DC12

- Pathway: 510(k) (Traditional)
- Applicant: Guided Delivery Systems
- Decided: Apr 16, 2010 after 87 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K893658 (1989). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091367: GDS-DCS, Guided Delivery Systems (2009) Summary page 1.
- K043489: Enpath Deflectable Catheter, Enpath Medical Incorporated (2005) Summary page 1.

## Indications for use
GDS-DC12 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.

Source page: https://510kreport.com/device/K100135
Methodology: https://510kreport.com/methodology