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U.S. Department of Health and Human Services

Product Classification
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Device catheter, pressure monitoring, cardiac
Regulation Description Diagnostic intravascular catheter.
Definition To measure pressure within the cardiovascular system.
Physical State Catheter with sensors.
Technical Method The catheter uses sensors which directly measure the pressure.
Target Area Cardiovascular system.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOBI
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
Third Party Review Not Third Party Eligible
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