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U.S. Department of Health and Human Services

Product Classification

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Device gauge, pressure, coronary, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass coronary pressure gauge.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDXS
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4310
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
Accredited Persons
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