# K992863: Lead Stylet,Models 6505,6506,6507,6508

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Nov 12, 1999 after 79 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 K905674 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Cited in the summary but kept off the family tree
- K893957: stylets currently packaged with leads. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K932103: stylets currently packaged with leads. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
These stylets are wires intended to facilitate the placement of pacmg leads during pacemaker implant procedures. The straight stylets are used to direct passage of a lead to the appropriate heart chamber and to wedge the lead in the trabeculae of the ventricle. The J-shaped stylets are used to direct passage of a lead in the atrium.

Source page: https://510kreport.com/device/K992863
Methodology: https://510kreport.com/methodology