# K905403: Model 340 Series Unipolar & Model 5000B Programmer

- Pathway: 510(k) (Traditional)
- Applicant: Cook Pacemaker Corp.
- Decided: Oct 16, 1991 after 317 days
- Product code: DXY (Implantable Pacemaker Pulse-Generator)
- Device class: 3
- Regulation: 21 CFR 870.3610
- 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 has not posted a summary or statement for it, so its predicates are not known.

Source page: https://510kreport.com/device/K905403
Methodology: https://510kreport.com/methodology