# K883743: Medtronic Model 4058 Pacing Lead

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jan 17, 1989 after 138 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962036: Medtronic Model 5058 Bipolar, Implantable, Screw-in, Ventricular/Atrial, Transvenous Lead (1996), 0 descendants of its own

## Recalls of this device
- Sep 15, 2015 · Class II · Z-0022-2016: Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted lead

Source page: https://510kreport.com/device/K883743
Methodology: https://510kreport.com/methodology