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U.S. Department of Health and Human Services

Product Classification
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Device optical coherence tomography, intravascular catheter
Definition For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.
Physical State A flexible intravascular catheter provides optical delivery and sensing of laser light to produce images of the vessel lumen and wall on its associated imaging system using optical coherence tomography technology.
Technical Method A flexible intravascular catheter provides optical delivery and sensing of laser light to produce images of the vessel lumen and wall on its associated imaging system using optical coherence tomography technology.
Target Area Coronary vasculature
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeORD
Premarket Review Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.1200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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