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510(k) K821826

FEP-RINGED GORE-TEX@ VASCULAR GRAFT by W.L. Gore & Associates, Inc. — Product Code DYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1982
Date Received
June 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

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  • 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)

Other clearances for product code DYF

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  • K000504 — ADVANTA SUPER SOFT GRAFT (March 1, 2000)
  • K992958 — ADVANTA GRAFT (<6MM) (October 1, 1999)
  • K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT (September 8, 1999)
  • K992441 — ADVANTA GRAFT (August 20, 1999)
  • K984183 — PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 (February 1, 1999)
  • K983769 — DISTAFLO BYPASS GRAFT (December 15, 1998)
  • K981076 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (May 7, 1998)
  • K964877 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (March 20, 1997)
  • K960766 — MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (March 19, 1997)