# K120296: CPS Direct Mediguide Enabled Outer Catheter

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
- Decided: May 11, 2012 after 101 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 K926514 (1993). 74 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 76 devices in its family (counting itself) has 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.
- K091781: Guided Medical Positioning System (GMPS), Mediguide, Ltd. (2009) Summary page 1.

## Most influential descendants
- K142239: CPS Direct MediGuide Enabled outer catheter (2014), 0 descendants of its own

## Indications for use
The St. Jude Medical CPS Direct, Mediguide Enabled 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. The CPS Direct, Mediguide Enabled slittable outer guide catheter are used with the Mediguide System to enable real-time tip positioning and navigation. The Mediguide system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct, Mediguide Enabled slittable outer guide catheters can work with inner catheters as a system.

Source page: https://510kreport.com/device/K120296
Methodology: https://510kreport.com/methodology