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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device angioscope
Regulation Description Endoscope and accessories.
Product CodeLYK
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
CARDIO-OPTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENDOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIMEDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Loss of power 1
Unable to obtain readings 1
Total Device Problems 2

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