# K970469: Evt Angioscale Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Cardiac and Vascular Surgery
- Decided: May 8, 1997 after 90 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
Longest line of descent: 1 generation back to K862006 (1986). 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)
- K862006: Stand & High Flow Femoral-Ventricular Pigtail Cath, Cordis Corp. (1986) Summary page 1.
- K914007: Cordis 5.2 French Super Torque Plus Cardio Cath, Cordis Corp. (1991) Summary page 1.
- (no number) Cordis Quanticor Marker Catheter: named in the summary without a submission number
- (no number) Cordis Ducor Angiographic Catheter: named in the summary without a submission number

## Indications for use
The EVT AngioScale angiography catheters provides angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

Source page: https://510kreport.com/device/K970469
Methodology: https://510kreport.com/methodology