GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE— 510(k) K082356

Name: FDA 510(k) clearance K082356
Creator: U.S. Food and Drug Administration
Published: 2008-08-28

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K082356 for GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE, Substantially Equivalent on 2008-08-28. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2008-08-18
Decision date: 2008-08-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

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K232312 — GORE® PROPATEN® Vascular Graft2024-01-09
K233551 — GORE® ACUSEAL Vascular Graft2023-12-19
K231505 — GORE® ACUSEAL Vascular Graft2023-06-23

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.