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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, vascular graft, of less then 6mm diameter
Regulation Description Vascular graft prosthesis.
Product CodeDYF
Regulation Number 870.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - POSTMARKET SURVEILLANCE 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT - POSTMARKET SURVEILLANCE 1
C.R. BARD, INC.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - POSTMARKET SURVEILLANCE 1
POSSIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SE SUBJECT TO TRACKING REG 2
  SE SUBJECT TO TRAKING & PMS 1
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Leak 3
Tears, rips, holes in device, device material 2
Other (for use when an appropriate device code cannot be identified) 1
No Known Device Problem 1
Explanted 1
Occlusion within device 1
Replace 1
Suture line disruption 1
Total Device Problems 11

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