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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device optical coherence tomography, intravascular catheter
Regulation Description Diagnostic intravascular catheter.
Definition For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.
Product CodeORD
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Poor Quality Image 1 1
Contamination /Decontamination Problem 1 1
Difficult to Insert 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Arrhythmia 1 1
Vascular Dissection 1 1
Vasoconstriction 1 1
Cardiac Perforation 1 1

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