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U.S. Department of Health and Human Services

Product Classification

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Device clip, vena-cava
Regulation Description Vena cava clip.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDST
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.3260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible