# K932172: Medtronic Models 4057M,4058M,4557M, Pacing Leads

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Dec 8, 1993 after 217 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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/K932172
Methodology: https://510kreport.com/methodology