# K092075: CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003, DS2C004, DS2C005

- Pathway: 510(k) (Special)
- Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
- Decided: Aug 7, 2009 after 29 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K130257: CPS Direct Universal Slittable Outer Catheter (2013), 1 descendant of its own
- K120296: CPS Direct Mediguide Enabled Outer Catheter (2012), 1 descendant of its own
- K231311: CPS Direct™ Universal slittable outer guide catheter (DS2C029) (2023), 0 descendants of its own
- K142239: CPS Direct MediGuide Enabled outer catheter (2014), 0 descendants of its own

## Indications for use
The St. Jude Medical CPS Direct® SL II Slittable Outer Catheters intended use 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, the outer guide catheters can work with inner catheters as a system.

Source page: https://510kreport.com/device/K092075
Methodology: https://510kreport.com/methodology