# K972814: Locator Model 4036

- Pathway: 510(k) (Traditional)
- Applicant: Pacesetter, Inc.
- Decided: Feb 23, 1998 after 209 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Pacesetter ball-tipped stylets - straight and j-shaped: named in the summary without a submission number

## Most influential descendants
- K040001: Steerable Stylet (2004), 0 descendants of its own

## Indications for use
The Locator™ Steerable Stylet is intended for use when implanting the Pacesetter Tendril™ model 1188 T/K pacemaker leads, in 46, 52, and 58 cm lengths in patients requiring long-term lead implantation to provide cardiac pacing.

Source page: https://510kreport.com/device/K972814
Methodology: https://510kreport.com/methodology