# K990726: Envy Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Apr 2, 1999 after 28 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 K974774 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974774: Envy Guiding Catheter, Cook, Inc. (1998) Summary page 2.

## 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. Not intended for cerebral vascular use.

Source page: https://510kreport.com/device/K990726
Methodology: https://510kreport.com/methodology