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U.S. Department of Health and Human Services

Product Classification
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Device stent, central venous
Definition A central venous stent is a prescription device for maintaining the luminal diameter of the central veins.
Physical State A metal scaffold placed via a delivery catheter.
Technical Method A metal scaffold placed via a delivery catheter in the central veins to maintain the lumen.
Target Area Central veins.
Review Panel Cardiovascular
Product CodeQKJ
Premarket Review Office of Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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