# K032073: Gore Introducer Sheath with Silicone Pinch Valve

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Aug 13, 2003 after 41 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
No predicates in its family tree.
42 later devices descend from it; 3 cite it directly.
3 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K082356: Gore Introducer Sheath with Silicone Pinch Valve (2008), 41 descendants of its own
- K093791: Gore Dryseal Sheath (2010), 32 descendants of its own
- K121234: Gore (R) Dryseal Sheath with Hydrophilic Coating (2012), 18 descendants of its own
- K160254: GORE DrySeal Flex Introducer Sheath (2016), 9 descendants of its own
- K123990: Sentrant Introducer Sheath with Hydrophilic Coating (2013), 7 descendants of its own

## Indications for use
Intended to be inserted in the peripheral vasculature to provide a conduit for the insertion of endovascular devices

Source page: https://510kreport.com/device/K032073
Methodology: https://510kreport.com/methodology