# K142239: CPS Direct MediGuide Enabled outer catheter

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Dec 18, 2014 after 127 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: 13 generations back to K926514 (1993). 75 ancestors in all.
No later device cites it as a predicate yet.
1 of 76 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120296: CPS Direct Mediguide Enabled Outer Catheter, St. Jude Medical, Cardiac Rhythm Management Divisi (2012) Summary page 4.

## 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/K142239
Methodology: https://510kreport.com/methodology