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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Flexible intravascular catheter with plaque diagnostic modality at the tip.
Technical Method The device is inserted into the arterial segment of interest, and using its sensing technology, obtains information on the characteristics of the arterial wall. The characteristics are captured digitally and filtered with a software algorithm, and the arterial wall and lesion characteristics are presented to the user via a user interface.
Target Area Coronary or peripheral arteries.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOGZ
Premarket Review Office of 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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible