# K063658: Intravascular Introducer System

- Pathway: 510(k) (Special)
- Applicant: Applied Medical Resources Corp.
- Decided: Sep 12, 2007 after 278 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: 2 generations back to K890766 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041506: Intravascular Access Introducer Sheath, Applied Medical Resources Corp. (2004) Summary page 1.
- 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

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

Source page: https://510kreport.com/device/K063658
Methodology: https://510kreport.com/methodology