# K053277: CPS Direct SL Outer Catheter

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Feb 24, 2006 after 93 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K893658 (1989). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021587: Attain LDS 6216A Left-Heart Delivery System, Model 6216A, Medtronic Vascular (2002) Summary page 1.
- K021589: Attain Access 6218A Left-Heart Delivery System, Model 6218, Medtronic Vascular (2002) Summary page 1.
- K031505: Rapido Cut-Away Guiding Catheter, Guidant Corporation (2003) Summary page 1.
- K042194: Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery, Medtronic Vascular (2004) Summary page 2.

## Recalls of this device
- Mar 20, 2007 · Not classified · Z-0933-2007: Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.

## Indications for use
The St. Jude Medical Slittable DirectTM 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, the outer guide catheters can work with inner catheters as a system.

Source page: https://510kreport.com/device/K053277
Methodology: https://510kreport.com/methodology