# K984062: Seal-Away Hemostasis Adapter, Model 406229

- Pathway: 510(k) (Traditional)
- Applicant: Diag Corp.
- Decided: Mar 24, 1999 after 128 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
Longest line of descent: 1 generation back to K894343 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894343: Daig Percutaneous Catheter Intro. & Removable Hemo, Daig Corp. (1989) Summary page 1.

## Indications for use
The Seal-Away™ Hemostasis Adapters are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.

Source page: https://510kreport.com/device/K984062
Methodology: https://510kreport.com/methodology