# K031906: Apeel CS Catheter Delivery System

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jul 18, 2003 after 28 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Seal-Away CS Introducer Kit: named in the summary without a submission number
- (no number) Seal-Away Hemostasis Adapter: named in the summary without a submission number
- (no number) Alliance Catheter Delivery System: named in the summary without a submission number

## Most influential descendants
- K050808: Coronary Sinus Access Kit, Model KCS8F-01 (2005), 1 descendant of its own
- K062340: Cardiooptics Augmentative Cardiac Optical Imaging System (2006), 0 descendants of its own

## Indications for use
The Apeel CS 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/K031906
Methodology: https://510kreport.com/methodology