# K132008: 6981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead Adaptor Kit, 5866-38M Lead Adap

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jul 30, 2013 after 29 days
- Product code: DTD (Pacemaker Lead Adaptor)
- Device class: 2
- Regulation: 21 CFR 870.3620
- 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 K911827 (1991). 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)
- K911827: Model 5866-9M & Model 6981M, Metronic, Inc. (1991) Summary page 2.
- K915724: Model 6984M Lead Extender Kit, Medtronic Vascular (1992) Summary page 2.
- K911302: Models 5866-24M/5866-38M/5866-40M/6986M Adapt Kit, Medtronic Vascular (1991) Summary page 2.

## Indications for use
The 698I1M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (I S-I UNI) standard. The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS- I BI1) standard. The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard. The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS- I UN!) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard. The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard and has a short-pin cavity and no sealing rings. The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS- I B1) standard.

Source page: https://510kreport.com/device/K132008
Methodology: https://510kreport.com/methodology