Gore DrySeal Sheath

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K120428 ↗

FDA product code

DYB

Device class

Class II

Regulation

21 CFR Part 870.1340

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

• GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

  Class III

  CE/MDR MDR 732278 Expiring Valid to Feb 2027

• GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface

  Class III

  CE/MDR MDR 731181 Active Valid to Jul 2031

• GORE-TEX® Stretch Vascular Graft

  Class III

  CE/MDR MDR 732281 Active Valid to Jul 2031

• GORE® EXCLUDER® Iliac Branch Endoprosthesis

  Class III

  CE/MDR MDR 731176 Active Valid to Jul 2031

• GORE® DrySeal Flex Introducer Sheath

  Class III

  CE/MDR MDR 764343 Active Valid to Apr 2028

• GORE® EXCLUDER® Conformable AAA Endoprosthesis

  Class III

  CE/MDR MDR 731175 Active Valid to Jul 2031

See all devices from W. L. Gore & Associates, Inc. →

• What is the Gore DrySeal Sheath primarily used for in clinical settings?

  The Gore DrySeal Sheath is designed for use in interventional radiology and cardiology procedures to help insert endovascular devices. Its DrySeal valve mechanism keeps blood from leaking during the procedure, reducing blood loss while the sheath is in place. The hydrophilic coating also improves flexibility and kink resistance, making it easier to navigate through blood vessels.

• Is the Gore DrySeal Sheath reusable, or is it meant for single-use only?

  The Gore DrySeal Sheath is explicitly supplied as a sterile, single-use product. This design ensures patient safety and hygiene by preventing cross-contamination between procedures, as reuse is not recommended or supported by the manufacturer.

• What components are included with each Gore DrySeal Sheath order?

  Each Gore DrySeal Sheath comes as a complete kit, including the introducer sheath with its DrySeal valve, a dilator for initial insertion, and a 2.5 ml valve inflation syringe. These components work together to facilitate hemostasis and smooth device insertion.

• How do I determine the correct size of Gore DrySeal Sheath for a patient?

  The Gore DrySeal Sheath sizes are specified by two measurements: the nominal body diameter (e.g., XXmm) and the minimum inner diameter (e.g., XXmm). These dimensions correspond to the vessel size where the sheath will be placed. Consult the product documentation or manufacturer guidelines to select the appropriate size based on the patient’s anatomy and the intended procedure.

• What special handling or storage instructions should I follow for the Gore DrySeal Sheath?

  Since the Gore DrySeal Sheath is sterile and single-use, it should be stored in its original packaging until ready for use to maintain sterility. Avoid exposure to extreme temperatures, moisture, or direct sunlight. Once opened, the sheath must be used immediately and not stored for future procedures.