# K965247: Envoy Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Jul 23, 1997 after 211 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: 1 generation back to K925131 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962362: Cordis Envoy & Vista Brite Tip Guiding Catheters, Cordis Corp. (1996) Summary page 1.
- K925131: Cordis 9 F Guiding Catheter, Cordis Corp. (1993) Summary page 1.

## Indications for use
The ENVOY Guiding Catheters are intended for the intravascular introduction of interventional/diagnostic devices in the peripheral, coronary and neurovasculature systems.

Source page: https://510kreport.com/device/K965247
Methodology: https://510kreport.com/methodology