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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, intravascular, plaque morphology evaluation
Regulation Description Diagnostic intravascular catheter.
Definition Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques.
Product CodeOGZ
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
INFRAREDX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4 4
2022 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 2 2
Break 1 1
No Display/Image 1 1
Entrapment of Device 1 1
Physical Resistance/Sticking 1 1
Difficult to Advance 1 1
Insufficient Information 1 1
Positioning Problem 1 1
Difficult to Insert 1 1
Delivered as Unsterile Product 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
No Consequences Or Impact To Patient 2 2
Unspecified Vascular Problem 2 2
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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