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510(k) Data Aggregation

    K Number
    K002352
    Device Name
    JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    2001-09-06

    (400 days)

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

    JMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002394
    Device Name
    JMS APHERESIS NEEDLE SET ACCORDION TYPE
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    2001-09-05

    (394 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    JMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010406
    Device Name
    JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    2001-06-20

    (128 days)

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

    JMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010410
    Device Name
    JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    2001-06-20

    (128 days)

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

    JMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000843
    Device Name
    MODIFICATION TO JMS APHERESIS NEEDLE
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    2000-04-10

    (26 days)

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

    JMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000845
    Device Name
    MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    2000-04-10

    (26 days)

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

    JMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K991904
    Device Name
    MODIFICATION OF JMS NEEDLES AND JMS SYRINGES
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    1999-08-31

    (88 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    JMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JMS Needle is intended to be used for infusion of drug, collecting solution or blood. Insert the Needle to patient's body and use it as a fluid pathway which connects inside and outside of the body. JMS Syringe is intended to be used for infusion of solution or collecting blood connecting JMS Needle. It is also used for continuous drug infusion put in Syringe Pump. JMS Needle and JMS Syringe must be discarded after one time use.
    Device Description
    Not Found
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    K Number
    K990470
    Device Name
    JMS A. V. FISTULA NEEDLE SET
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    1999-08-30

    (195 days)

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

    JMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use for temporary cannulation for vascular access for extracorporeal blood treatment. This device is intended to single use only and is for temporary catheterization less than 30 days. Regarding to pre-attached Anti-stick device, use for prevention of needlestick injury at the time of needle withdrawal after usage.
    Device Description
    Needle, Fistula
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    K Number
    K990510
    Device Name
    JMS APHERESIS NEEDLE
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    1999-08-30

    (193 days)

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

    JMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to provide access to a patient's blood for Apheresis. This device is intended to single use only and is for temporary catheterization less than 30 days. Regarding to pre-attached Anti-stick Device, use for prevention of needlestick injury a the time of needle withdrawal after usage.
    Device Description
    Apheresis Needle
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    K Number
    K983707
    Device Name
    JMS DIALYZER PRIMING SET
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    1999-01-08

    (79 days)

    Product Code
    KOC
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    JMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is connected with Blood Tubing Set and used to prime Dialyzer and Blood Tubing Set. JMS Dialyzer Priming Set must be discarded after one time use.
    Device Description
    Not Found
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