# K984482: Ave GL-1 Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arterial Vascular Engineering Massachusetts, Inc.
- Decided: Jul 30, 1999 after 226 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) AVEM Mainstay™ Guiding Catheter: named in the summary without a submission number
- (no number) ACS Guidant Viking™ Guiding Catheter: named in the summary without a submission number
- (no number) Cordis Brite™ Tip Guiding Catheter: named in the summary without a submission number
- (no number) Schneider Guider™ Guiding Catheter: named in the summary without a submission number

## Indications for use
AVE guiding catheters are designed for use in the vascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. AVE Guiding catheters also allow pressure monitoring and injection of contrast agents.

Source page: https://510kreport.com/device/K984482
Methodology: https://510kreport.com/methodology