# K012459: Model 6494 Unipolar Temporary Myocardial Pacing Wire

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Aug 14, 2001 after 13 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 3 cite it directly.
0 of 27 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) Model 6494 Unipolar Temporary Myocardial Pacing Wire: named in the summary without a submission number

## Most influential descendants
- K040812: Detect Surgical Pacing and Mapping Tool (2004), 20 descendants of its own
- K051749: Cobra Surgical System (2005), 19 descendants of its own
- K061593: Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1 (2006), 13 descendants of its own
- K100501: Multifunctional Linear Pen (2010), 9 descendants of its own
- K113475: Estech Cobra Adhere XL 2 Surgical System (2012), 4 descendants of its own

## Indications for use
The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K012459
Methodology: https://510kreport.com/methodology
