# K130257: CPS Direct Universal Slittable Outer Catheter

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Mar 20, 2013 after 47 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: 1 generation back to K092075 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092075: CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005, St. Jude Medical, Cardiac Rhythm Management Divisi (2009) Summary page 1.

## Most influential descendants
- K231311: CPS Direct™ Universal slittable outer guide catheter (DS2C029) (2023), 0 descendants of its own

## Indications for use
The St. Jude Medical CPS DirectTM 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 St. Jude Medical devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, CPS Direct Universal slittable outer guide catheters can work with inner catheters as a system

Source page: https://510kreport.com/device/K130257
Methodology: https://510kreport.com/methodology