# K013029: Seal-Away CS Introducer Kit, Models 407514, 407515

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Oct 9, 2001 after 29 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Peel away Sheath Introducer and Obturator: named in the summary without a submission number

## Most influential descendants
- K230283: Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) (2023), 0 descendants of its own

## Indications for use
The Seal-Away CS™ Introducer Kit is a percutaneous catheter introducer kit with peel-away sheath that is indicated for the introduction of catheters into a vessel. The Seal-Away™ Hemostasis Adapter is indicated for the introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.

Source page: https://510kreport.com/device/K013029
Methodology: https://510kreport.com/methodology