# K041506: Intravascular Access Introducer Sheath

- Pathway: 510(k) (Special)
- Applicant: Applied Medical Resources Corp.
- Decided: Oct 15, 2004 after 130 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 K890766 (1989). 1 ancestor in all.
1 later device descends 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)
- K890766: Catheter Introducer Sheath, Applied Vascular Devices, Inc. (1989) Summary page 1.
- (no number) Johnson & Johnson Cordis Avanti+ Introducer Set: named in the summary without a submission number

## Most influential descendants
- K063658: Intravascular Introducer System (2007), 0 descendants of its own

## Indications for use
The Applied Medical Intravascular Access Introducer Sheath is indicated for percutaneous access to the peripheral vascular Sheath and is designed to assist in the placement and removal of catheters.

Source page: https://510kreport.com/device/K041506
Methodology: https://510kreport.com/methodology