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U.S. Department of Health and Human Services

Product Classification

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Device tubing, pump, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass pump tubing.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDWE
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Prostheses (DHT2B)
Submission Type 510(k)
Regulation Number 870.4390
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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