# K053217: CPS Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Mar 8, 2006 after 111 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 5 (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). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042194: Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery, Medtronic Vascular (2004) Summary page 1.
- K021455: Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777, 6778, 6779, 6780, 6781, 6782,, Guidant Corp. (2002) Summary page 1.

## Recalls of this device
- Jun 1, 2006 · Not classified · Z-1165-06: Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
- Jun 1, 2006 · Not classified · Z-1164-06: Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
- Jun 1, 2006 · Not classified · Z-1166-06: Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
- Jun 1, 2006 · Not classified · Z-1167-06: Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
- Jun 1, 2006 · Not classified · Z-1168-06: Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

## Indications for use
The St. Jude Medical CPS AimTM Inner Catheter 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 guidewires. In addition, the inner catheters can work with outer guide catheters as a system.

Source page: https://510kreport.com/device/K053217
Methodology: https://510kreport.com/methodology