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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 Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.3260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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