# K984627: Ave 4F Siteseer Cardiovascular Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arterial Vascular Engineering, Inc.
- Decided: Jul 27, 1999 after 209 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.
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) AVE SiteSeer™ Catheter: named in the summary without a submission number
- (no number) AVE Envision™ Catheter: named in the summary without a submission number
- (no number) Cordis Infiniti™ Angiographic Catheter: named in the summary without a submission number
- (no number) Cordis Vista™ Bright tip Catheter: named in the summary without a submission number

## Indications for use
An intravascular diagnostic catheter is a device used to record intracardiac pressure, to sample blood, and to introduce substances into the heart and vessels.

Source page: https://510kreport.com/device/K984627
Methodology: https://510kreport.com/methodology