# K042190: Model 6416 Temporary Pacing Lead System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Sep 7, 2004 after 26 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) current market released Model 6416 Bipolar Transvenous Temporary Pacing System: named in the summary without a submission number

## Most influential descendants
- K160260: Tempo Temporary Pacing Lead (2016), 1 descendant of its own
- K252042: Sync AV II Temporary Pacing Catheter (2026), 0 descendants of its own

## Recalls of this device
- Jun 16, 2016 · Class II · Z-2200-2016: This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patients lead to a

## Indications for use
The Model 6416 Bipolar Transvenous Temporary Pacing System features an active fixation, bipolar lead and a soft-tipped lubricated guide catheter. The system is designed for temporary intracardiac pacing and/or EGM recording. The system is disposable, for temporary single patient use with a contemplated implant duration of 7 days or less. The lead and accessories are supplied sterile. The lead is introduced transvenously using the guide catheter. Once within the appropriate chamber, the helical tip electrode of the lead is actively fixed into the endocardium. After lead placement, the guide catheter is removed by sliding it over the lead's bifurcated connector.

Source page: https://510kreport.com/device/K042190
Methodology: https://510kreport.com/methodology