# K142235: CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner 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: 6 generations back to K934139 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090613: CPS Aim SL Slittable Inner Catheters, Models DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2, St. Jude Medical, Cardiac Rhythm Management Divisi (2009) Summary page 4.
- K091780: Guided Measurement Catheter (GMC), Mediguide, Ltd. (2009) Summary page 4.

## Indications for use
The St. Jude Medical™ CPS Aim™, MediGuide Enabled™ slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection 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 leads and guidewires. In addition, CPS Aim™, MediGuide Enabled™ slittable inner catheters (subselector/cannulator) can work with outer guide catheters as a system. The CPS Aim™, MediGuide Enabled™ slittable inner catheter is used with the MediGuide™ System to enable realtime tip positioning and navigation within the anatomy. The MediGuide™ system is indicated for use as an adjunct to fluoroscopy.

Source page: https://510kreport.com/device/K142235
Methodology: https://510kreport.com/methodology