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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 Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.3535
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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