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U.S. Department of Health and Human Services

Product Classification

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Device system, balloon, intra-aortic and control
Regulation Description Intra-aortic balloon and control system.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDSP
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.3535
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible