# K041574: Cpi Lead Adapters, Models 6017, 6018 and 6020

- Pathway: 510(k) (Special)
- Applicant: Guidant Corporation
- Decided: Jul 12, 2004 after 28 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1) Model 6017: It is designed to join CPI bipolar leads having 3.2mm inline connectors to 5mm (4.75) bifurcated bipolar terminals. 2) Model 6018: It is a single barrel adapter that is designed to join CPI unipolar leads having a 6mm (5.38) unipolar connector to 3.2mm low profile unipolar terminal. 3) Model 6020: It is a single barrel adapter that is designed to join CP1 unipolar leads having a 5mm (4.75) unipolar connector to 3.2mm low profile unipolar terminal.

Source page: https://510kreport.com/device/K041574
Methodology: https://510kreport.com/methodology