# K121234: Gore (R) Dryseal Sheath with Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Nov 20, 2012 after 210 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: 3 generations back to K032073 (2003). 4 ancestors in all.
18 later devices descend from it; 4 cite it directly.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093791: Gore Dryseal Sheath, W. L. Gore & Associates, Inc. (2010) Summary page 2.

## Most influential descendants
- K160254: GORE DrySeal Flex Introducer Sheath (2016), 9 descendants of its own
- K212392: Intri24 Sheath (2022), 5 descendants of its own
- K230331: Protrieve Sheath (2023), 2 descendants of its own
- K222113: Abiomed 14Fr Low Profile Introducer Set (2022), 2 descendants of its own
- K241708: Abiomed 14Fr Low Profile Introducer Kit (2024), 1 descendant of its own

## Indications for use
The GORE® DrySeal Sheath with hydrophilic coating is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

Source page: https://510kreport.com/device/K121234
Methodology: https://510kreport.com/methodology