# K231311: CPS Direct™ Universal slittable outer guide catheter (DS2C029)

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Jun 2, 2023 after 28 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: 2 generations back to K092075 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130257: CPS Direct Universal Slittable Outer Catheter, St Jude Medical (2013) Summary page 5.

## Indications for use
The CPS Direct ™ Universal slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and other devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, the CPS Direct Universal slittable outer guide catheters can work with inner catheters as a system.

Source page: https://510kreport.com/device/K231311
Methodology: https://510kreport.com/methodology