# K963898: Model 6495 Bipolar Temporary Pacing Lead

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jul 22, 1997 after 298 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
Longest line of descent: 1 generation back to K850622 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944957: Temporary Myocardial Pacing Lead, Model 6500, Medtronic Blood Systems, Inc. (1995) Summary page 1.
- K850622: Oscor Medical Model Tme 64S Bipolar Temp/Heart Wir, Oscor Medical Corp. (1985) Summary page 1.

## Recalls of this device
- Feb 6, 2009 · Not classified · Z-1173-2009: Medtronic is recalling one lot of STREAMLINE Bipolar Myocardial Temporary Pacing Leads, Model 6495, Lot JGD880205F. This lot of product contains incorrect inner pouch labeling, instead of 6495 it is l

## Indications for use
The Model 6495 bipolar temporary myocardial pacing lead is designed for temporary atrial and ventricular pacing and sensing, for a maximum of 7 days, during and after cardiac surgery. The Model 6495 bipolar temporary myocardial pacing lead is intended for SNGLE USE ONLY.

Source page: https://510kreport.com/device/K963898
Methodology: https://510kreport.com/methodology