# K974774: Envy Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Oct 16, 1998 after 298 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COOK Coronary Guiding Catheter: named in the summary without a submission number

## Most influential descendants
- K990726: Envy Guiding Catheter (1999), 0 descendants of its own

## Indications for use
Used for the delivery of PTCA balloons and other various types of interventional cardiology devices. They are intended for use by physicians trained and experienced in PTCA and interventional cardiology techniques. Intended for single procedure use. Supplied sterile in peel-open packages

Source page: https://510kreport.com/device/K974774
Methodology: https://510kreport.com/methodology