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510(k) Data Aggregation

    K Number
    K152183
    Device Name
    EXELINT SecureTouch Safety Hypodermic Needle
    Manufacturer
    EXELINT INTERNATIONAL CO.
    Date Cleared
    2015-11-02

    (89 days)

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

    EXELINT INTERNATIONAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EXELINT SecureTouch Safety Hypodermic Needle is intended for use with syringes for general purpose aspiration and medication administration. It has an antistick mechanism to cover the needle after use.
    Device Description
    EXELINT SecureTouch Safety Hypodermic Needle is a sterile, single use, standard luer lock compatible hypodermic needle with a protection shield to enclose the needle after use The device is available in 18 to 30 gauge in length from 10mm to 50mm. The purpose of this submission is to enable Exelint International, Co. to market a line of safety hypodermic needle. The proposed device is available in EO sterilized sealed in a sterility maintenance package.
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    K Number
    K101309
    Device Name
    EXELINT ALUMINUM HUB BLUNT NEEDLES
    Manufacturer
    EXELINT INTERNATIONAL CO.
    Date Cleared
    2010-10-20

    (163 days)

    Product Code
    LHI, FMI
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXELINT INTERNATIONAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EXELINT Aluminum Hub Blunt Needles are intended to be used in a variety of medical, pharmaceutical and laboratory procedures to extract fluid or medication from vials or ampoule for transfer or for irrigation.
    Device Description
    The EXELINT Aluminum Hub Blunt Needles are sterile, non-pyrogenic, single use fluid transfer needles consisting of blunt Type 304 stainless steel cannulas staked into aluminum luer lock hubs. The gauge and length of the cannula determines the final gauge and length of the product. The hubs are identical for all of the needles. Each needle is packaged into a Polypropylene tube and sealed with a polypropylene cap. The needles are final packaged into a multineedle box and ETO sterilized.
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    K Number
    K020189
    Device Name
    EXEL BUTTERFLY SCALP VEIN SET
    Manufacturer
    EXELINT INTERNATIONAL CO.
    Date Cleared
    2003-03-27

    (433 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXELINT INTERNATIONAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EXEL Scalp Vein (butterfly) set is used for administration of IV solution or infusion of medication to the patient via vascular system.
    Device Description
    Not Found
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    K Number
    K010197
    Device Name
    EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
    Manufacturer
    EXELINT INTERNATIONAL CO.
    Date Cleared
    2001-05-14

    (112 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXELINT INTERNATIONAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003627
    Device Name
    EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
    Manufacturer
    EXELINT INTERNATIONAL CO.
    Date Cleared
    2001-02-08

    (76 days)

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

    EXELINT INTERNATIONAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001496
    Device Name
    A.V. FISTULA NEEDLE
    Manufacturer
    EXELINT INTERNATIONAL CO.
    Date Cleared
    2000-08-01

    (78 days)

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

    EXELINT INTERNATIONAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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