# K221750: CPS AIM Universal II Slittable Inner Catheter

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Jun 30, 2022 after 14 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: 2 generations back to K090613 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130252: CPS Aim Universal Slittable Inner Catheter, St Jude Medical (2013) Summary page 4.

## Indications for use
The CPS Aim™ Universal II 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 delivery of contrast medium and Abbott Medical devices (such as guidewires and implantable left heart leads). In addition, the CPS Aim™ Universal II slittable inner catheter (subselector/cannulator) can work with outer guide catheters as a system.

Source page: https://510kreport.com/device/K221750
Methodology: https://510kreport.com/methodology