# K171206: D'Vill Introducer

- Pathway: 510(k) (Traditional)
- Applicant: NuMED, Inc.
- Decided: Oct 20, 2017 after 178 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: 5 generations back to K032073 (2003). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160254: GORE DrySeal Flex Introducer Sheath, W. L. Gore & Associates, Inc. (2016) Summary page 4.
- K121234: Gore (R) Dryseal Sheath with Hydrophilic Coating, W. L. Gore & Associates, Inc. (2012) Summary page 4.

## Most influential descendants
- K190974: D'Vill Introducer (2019), 0 descendants of its own

## Indications for use
Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K171206
Methodology: https://510kreport.com/methodology