# K053019: Acuity Steerable Stylet Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corporation
- Decided: Mar 3, 2006 after 128 days
- Product code: DRB (Stylet, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1380
- 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 K843060 (1984). 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)
- K905674: Lead Stylet, Cardiac Pacemakers, Inc. (1991) Summary page 1.
- K843060: Sentra, Cardiac Pacemakers, Inc. (1984) Summary page 1.

## Indications for use
For use with compatible, transvenous, left ventricular, pace/sense leads

Source page: https://510kreport.com/device/K053019
Methodology: https://510kreport.com/methodology