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510(k) K953287

DIASTAT VASCULAR ACCESS GRAFT by W.L. Gore & Associates, Inc. — Product Code DYF

Clearance Details

Decision
ST ()
Decision Date
October 6, 1995
Date Received
July 13, 1995
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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  • K163576 — GORE SYNECOR Preperitoneal Biomaterial (May 11, 2017)
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  • 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)