# K962036: Medtronic Model 5058 Bipolar, Implantable, Screw-in, Ventricular/Atrial, Transvenous Lead

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Aug 22, 1996 after 90 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
Longest line of descent: 1 generation back to K883743 (1989). 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)
- K940703: Medtronic Model 4558M, Medtronic Vascular (1994) Summary page 1.
- K883743: Medtronic Model 4058 Pacing Lead, Medtronic Vascular (1989) Summary page 1.

## Indications for use
The model 5058 screw-in lead is indicated for pacing and sensing applications in either the atrium or the ventricle. This lead has application where implantable permanent atrial or ventricular, single chamber or dual chamber pacing systems are indicated. This permanent pacemaker lead is used to provide channeled electrically conductive pathways between the pulse generator and the heart.

Source page: https://510kreport.com/device/K962036
Methodology: https://510kreport.com/methodology