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U.S. Department of Health and Human Services

Product Classification
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Device reprocessed intravascular ultrasound catheter
Regulation Description Diagnostic intravascular catheter.
Definition For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Physical State Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.
Technical Method Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.
Target Area Cardiovascular anatomy and physiology.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOWQ
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
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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