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510(k) Data Aggregation

    K Number
    K152819
    Device Name
    Amecath Peripheral inserted Central Venous Catheter Sets
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2016-02-05

    (130 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMECO MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Amecath Peripheral Inserted Central Venous Catheter Sets are intended for use in attaining access to the central venous system for short or long-term use for venous pressure monitoring, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is indicated for multiple injections of contrast media through a power injector. The maximum pressure linetors used with the catheter may not exceed 300 psi and the flow rate may not exceed the maximum flow rate indicated.
    Device Description
    Not Found
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    K Number
    K131144
    Device Name
    AMECO SHEATH INTRODUCER
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2013-08-15

    (114 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMECO MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Percutaneous sheath introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature
    Device Description
    Not Found
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    K Number
    K131814
    Device Name
    AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2013-07-26

    (36 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMECO MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Amecath Dual Lumen Implanted Hemodialysis Catheter" is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown. Repair Kit is designed to replace worn or damaged extension connector adapters on the all catheter models: - . PDLC - . PYDLC - P2TC - . PXDLC Catheters are not intended for pediatric use.
    Device Description
    "Amecath Dual Lumen Implanted Hemodialysis Catheter" is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown.
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    K Number
    K123943
    Device Name
    AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2013-04-02

    (103 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMECO MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Amecath Dual Lumen Implanted Hemodialysis Catheter" is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown. Repair Kit is designed to replace worn or damaged extension connector adapters on the all catheter models: - . PDLC - PYDLC . - P2TC . - PXDLC . Catheters are not intended for pediatric use.
    Device Description
    "Amecath Dual Lumen Implanted Hemodialysis Catheter and Repair Kit"
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    K Number
    K110794
    Device Name
    AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2011-12-21

    (274 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMECO MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated to permit short-term (<30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following: - Lack of usable peripheral IV sites . - Central venous pressure monitoring . - Total parenteral nutrition (TPN) . - . Multiple infusions of fluids, medications, or chemotherapy - Frequent blood sampling or receiving blood transfusions/blood products . - . Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values - Injection of contrast media in pressure CVC only . When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 300psi.
    Device Description
    Not Found
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    K Number
    K110793
    Device Name
    AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2011-12-16

    (269 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMECO MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for acute hemodialysis and apheresis. They may be inserted perculaneously and are idealy placed in the internal jugularyon and apricless. They may be inserted percuraneously and an the internal jugular is the preferred site the preferred site.
    Device Description
    "Amecath" and "Amecath UniQath Soft" short term dual hemodialysis catheterization kits
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