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510(k) Data Aggregation
K Number
K133807Device Name
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
Manufacturer
GAMBRO RENAL PRODUCTS, INC.
Date Cleared
2014-03-26
(100 days)
Product Code
FLD, KDI
Regulation Number
876.5870Why did this record match?
Product Code :
FLD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MARS is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal and/or ion exchange resins.
The MARS is indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS treatments to significantly decrease their hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT).
The Prismaflex control unit is intended for:
- Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms . or more with acute renal failure and/or fluid overload.
- Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or . more with diseases where removal of plasma components is indicated.
- Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS . system to conduct MARS treatments for patients weighing 20 kilograms or more.
All treatments administered via the Prismaflex control unit must be prescribed by a physician.
Device Description
Not Found
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K Number
K113313Device Name
MOLECULAR ADSORBENT RECIRCULATING(MARS)
Manufacturer
GAMBRO RENAL PRODUCTS, INC.
Date Cleared
2012-12-14
(401 days)
Product Code
FLD
Regulation Number
876.5870Why did this record match?
Product Code :
FLD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MARS® is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal and/or ion exchange resins.
The MARS® is indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS® treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS® treatments to significantly decrease their hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT).
Device Description
The MARS® is a blood detoxification device comprised of dialyzers, adsorption columns, tubing connectors and a monitor unit. It is designed for the combined removal of watersoluble low and middle molecular weight substances and albumin bound molecules. The treatment is based on the dialysis of blood against an albumin-containing dialysate solution.
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K Number
K033262Device Name
MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
Manufacturer
GAMBRO RENAL PRODUCTS
Date Cleared
2005-05-27
(596 days)
Product Code
FLD
Regulation Number
876.5870Why did this record match?
Product Code :
FLD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MARS® is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal and/or ion exchange resins.
Device Description
The MARS® is a blood detoxification device comprised of dialyzers, adsorption columns, tubing connectors and a control unit. It is designed for the combined removal of water-soluble low and middle molecular weight substances and albumin bound molecules. The treatment is based on the dialysis of blood against an albumin-containing dialysate solution.
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K Number
K992196Device Name
BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
Manufacturer
HEMOCLEANSE, INC.
Date Cleared
1999-09-10
(72 days)
Product Code
FLD
Regulation Number
876.5870Why did this record match?
Product Code :
FLD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1) Acute Hepatic Encephalopathy: The BioLogic-DT System is indicatd for the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure.
2) Drug Overdose and Poisonings: The BioLogic-DT System is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal, such as acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, and insecticides.
Device Description
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K Number
K984546Device Name
BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
Manufacturer
HEMOCLEANSE, INC.
Date Cleared
1999-08-13
(234 days)
Product Code
FLD
Regulation Number
876.5870Why did this record match?
Product Code :
FLD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Acute Hepatic Encephalopathy: The BioLogic-DT System is indicated for the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure.
2. Drug Overdose and Poisonings: The BioLogic-DT System is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal, such as acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, and insecticides.
Device Description
The BioLogic-DT System is a sorbent regenerated detoxification system consisting of the BioLogic-DT Machine and the single use BioLogic-DT-1000-TK (Treatment Kit). In many ways, it is similar to a standard hemodialysis machine in that blood is removed from the body, passed through a cellulosic dialyzer, and returned to the body. Within the dialyzer, diffusion causes many chemicals and toxins to pass from the dialysate surrounding the membranes. Depending on the binding characteristics of the sorbents in suspension in the dialysate, some chemicals remain at low concentration in the dialysate, and are therefore efficiently removed from the blood, while others reach concentrations similar to blood, and are therefore not removed from the blood. Like existing single-access dialysis systems, the BioLogic-DT System alternately withdraws and returns blood through a single-lumen catheter. Unlike standard dialysis machines, which use roller pumps to pass blood through the membranes, the DT applies an alternating pressure/ vacuum cycle to the sorbent suspension causing the alternating expansion and compression of the dialyzer's parallel plate cellulosic membranes. This expansion and compression of the membranes is used to pump blood through the system.
An improvement in software of the DT-1000 System mixes the sorbents before prime, obviating the need for the operator to shake the bag.
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K Number
K971015Device Name
AHCS HEMOPERFUSION SYSTEM
Manufacturer
AMERICAN HEALTH CARE SYSTEMS, INC.
Date Cleared
1997-10-22
(216 days)
Product Code
FLD
Regulation Number
876.5870Why did this record match?
Product Code :
FLD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Blood detoxification and drug removal/retention
Device Description
AHCS Hemoperfusion System
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K Number
K953751Device Name
BIOLOGIC-DT SYSTEM
Manufacturer
HEMOCLEANSE, INC.
Date Cleared
1996-02-15
(189 days)
Product Code
FLD
Regulation Number
876.5870Why did this record match?
Product Code :
FLD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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