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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

Device Problems
No Known Device Problem 2
Physical resistance 1
Folded 1
Total Device Problems 4

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