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U.S. Department of Health and Human Services

Product Classification

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Device molecular adsorbent recirculating system (mars)
Definition The molecular adsorbent recirculating system (mars) is an albumin dialysis blood detoxification system designed for the combined removal of water-soluble low molecular weight substances and albumin-bound molecules in the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure. The mars system is also indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable and bound by albumin. The mars system is not indicated for the treatment of chronic liver disease or a bridge to liver transplant.
Review Panel Gastroenterology/Urology
Product CodeNKL
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible