# K973360: Medtronic Model 6416 Transvenous Bipolar Temporary Pacing Lead

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: May 26, 1998 after 260 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
Longest line of descent: 1 generation back to K772103 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K772103: Bipolar Leads, Disp., Medtronic Vascular (1977) Summary page 1.
- K790261: Medtronic Temptron, Medtronic Vascular (1979) Summary page 1.
- K950179: Medtronic (R) GC Iii Coronary Guiding Catheter, Medtronics Interventional Vascular (1995) Summary page 1.

## Indications for use
The Medtronic Model 6416 Temporary, Transvenous Pacing Lead 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/K973360
Methodology: https://510kreport.com/methodology