# K070865: Expanding Vascular Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical
- Decided: Oct 23, 2007 after 208 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.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963886: EVS, Applied Medical Resources (1997) Summary page 1.

## Most influential descendants
- K102925: Nexgen Expandable Catheter (2011), 0 descendants of its own

## Indications for use
The Applied Medical Expandable Vascular 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/K070865
Methodology: https://510kreport.com/methodology