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510(k) K000504

ADVANTA SUPER SOFT GRAFT by Atrium Medical Corp. — Product Code DYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2000
Date Received
February 15, 2000
Clearance Type
Special
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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Other clearances for product code DYF

  • K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (May 14, 2001)
  • 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)
  • K955533 — DIASTAT VASCULAR ACCESS GRAFT (May 15, 1996)