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U.S. Department of Health and Human Services

Product Classification

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Device prosthesis, vascular graft, of less then 6mm diameter
Regulation Description Vascular graft prosthesis.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDYF
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission Type 510(k)
Regulation Number 870.3450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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