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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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 3 3
2018 4 4
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 2 2
Poor Quality Image 1 1
Failure to Advance 1 1
Detachment of Device or Device Component 1 1
Device Packaging Compromised 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5 5
No Patient Involvement 2 2
Pericardial Effusion 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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