# K982220: Model 2872 Bipolar Lead Adaptor Kit

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Oct 15, 1998 after 113 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 K911302 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911302: Models 5866-24M/5866-38M/5866-40M/6986M Adapt Kit, Medtronic Vascular (1991) Summary page 1.

## Indications for use
The Model 2872 Lead Adaptor Kit is designed to connect two pacing leads with bipolar connectors (IS-1 BI)* to a pulse generator featuring a bipolar connector block which meets the IS-1 BI* standard. *IS-1 refers to an International Connector Standard (ISO 5841-3; 1992) whereby pulse generators and leads so designated are assured of a basic mechanical fit.

Source page: https://510kreport.com/device/K982220
Methodology: https://510kreport.com/methodology