# K051096: Apeel CS Plus Catheter Delivery System, Models 407579, 407580, 407581, 407582

- Pathway: 510(k) (Special)
- Applicant: St. Jude Medical, Daig Division, Inc.
- Decided: May 17, 2005 after 18 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 its predicate without a number.
- (no number) Apeel CS Catheter Delivery System: named in the summary without a submission number
- (no number) Spyglass Angiographic Catheter: named in the summary without a submission number

## Indications for use
The Apeel CS Plus Catheter Delivery System is intended to provide vascular access including the coronary sinus and serve as a conduit for the delivery and support of other devices where minimizing blood loss is essential.

Source page: https://510kreport.com/device/K051096
Methodology: https://510kreport.com/methodology