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U.S. Department of Health and Human Services

Product Classification

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Device syringe, balloon inflation
Regulation Description Angiographic injector and syringe.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeMAV
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission Type 510(k)
Regulation Number 870.1650
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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