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510(k) K250410

GORE® Tri-Lobe Balloon Catheter by W.L. Gore & Associates, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2025
Date Received
February 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by W.L. Gore & Associates, Inc.

  • K240083 — GORE® PROPATEN® Vascular Graft (March 1, 2024)
  • K232312 — GORE® PROPATEN® Vascular Graft (January 9, 2024)
  • K233551 — GORE® ACUSEAL Vascular Graft (December 19, 2023)
  • K231505 — GORE® ACUSEAL Vascular Graft (June 23, 2023)
  • K191773 — GORE BIO-A Tissue Reinforcement (July 31, 2019)
  • K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (August 17, 2018)
  • K173333 — GORE ENFORM Biomaterial (April 5, 2018)
  • K163576 — GORE SYNECOR Preperitoneal Biomaterial (May 11, 2017)
  • K170740 — GORE VIABIL Short Wire Biliary Endoprosthesis (May 8, 2017)
  • K163217 — GORE BIO-A Tissue Reinforcement (February 10, 2017)

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  • K250492 — FlexiGo 3D Delivery Catheter (June 18, 2025)