# K061710: CPS Direct PL Peelable Outer Guide Catheter; Accessory, Valve Bypass Tools

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jul 14, 2006 after 25 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The St. Jude Medical CPS Direct It Peelable Outer Guide Catheter 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 CPS Direct PL Peelable Outer Guide Catheters can work with inner catheters as a system.

Source page: https://510kreport.com/device/K061710
Methodology: https://510kreport.com/methodology