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510(k) K160254

GORE DrySeal Flex Introducer Sheath by W. L. Gore & Associates, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2016
Date Received
February 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K231505 — GORE® ACUSEAL Vascular Graft (June 23, 2023)
  • K222919 — GORE® ENFORM Biomaterial (December 19, 2022)
  • K191773 — GORE BIO-A Tissue Reinforcement (July 31, 2019)
  • K180919 — GORE Tri-Lumen Catheter (October 5, 2018)
  • K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (August 17, 2018)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)

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