# K132542: Transgate Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Neurovascular
- Decided: Nov 15, 2013 after 94 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: 2 generations back to K961999 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093184: Envoy Guiding Catheters, Codman & Shurtleff, Inc. (2009) Summary page 1.
- K010853: Guider Softip Guiding Catheter XF 5F, Boston Scientific, Target (2001) Summary page 3.
- K980453: Schneider Guider Softip Guiding Catheters, Boston Scientific Scimed, Inc. (1998) Summary page 1.

## Indications for use
TransGateTM Guide Catheters are intended to facilitate the placement of interventional devices into the coronary, peripheral, and neuro vasculature.

Source page: https://510kreport.com/device/K132542
Methodology: https://510kreport.com/methodology