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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device echocardiograph
Regulation Description Echocardiograph.
Product CodeDXK
Regulation Number 870.2330
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Tip 2
Detachment Of Device Component 2
Catheter 1
Device Contamination with Chemical or Other Material 1
Device Contaminated during manufacture or shipping 1
Break 1
Failure to Advance 1
Device Packaging Compromised 1
Detachment of Device or device Component 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 12


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