# K033858: Temporary Bipolar Myocardial Pacing Wire

- Pathway: 510(k) (Traditional)
- Applicant: European Custom Manufacturing BV
- Decided: Jul 12, 2004 after 214 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.
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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Apr 18, 2011 · Not classified · Z-1038-2012: The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality.

## Indications for use
The Temporary Bipolar Myocardial Pacing Wire functions as a temporary implant for the transmission of electrical heart pacing signals. The heart wire is placed following cardiac surgery to be in direct contact with the native myocardium while the natural heart is surgically exposed. The wire may be used on either the atrium or ventricle.

Source page: https://510kreport.com/device/K033858
Methodology: https://510kreport.com/methodology