# K963214: Cordis ST Steerable Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Nov 13, 1996 after 89 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K881897 (1988). 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)
- K953760: Cordis Wizdom Steerable Guidewire, Cordis Corp. (1995) Summary page 1.
- K881897: Acs HI-Torque Floppy/Floppy II/Inter./Standard GW, Advanced Cardiovascular Systems, Inc. (1988) Summary page 1.

## Indications for use
The Cordis ST Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K963214
Methodology: https://510kreport.com/methodology