# K250147: CPS Locator 3D Delivery Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Centerpoint Systems
- Decided: Aug 22, 2025 after 213 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K893658 (1989). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230363: CPS Locator 3D Delivery Catheter, CenterPoint Systems, LLC (2023) Summary page 5.

## Indications for use
The Delivery Catheter is indicated for the introduction of pacing and defibrillation leads to the right heart, inclusive of the Left Bundle Branch Area.

Source page: https://510kreport.com/device/K250147
Methodology: https://510kreport.com/methodology