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510(k) Data Aggregation

    K Number
    K092172
    Device Name
    EXEL I.V. EXTENSION SET
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2010-01-04

    (167 days)

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

    EXELINT INTL. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I.V. Extension Set is an accessory device used for infusion of medication intravenously into the patient.
    Device Description
    Not Found
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    K Number
    K052103
    Device Name
    EXEL SECURE TOUCH II SAFETY SYRINGE
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2005-10-19

    (77 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXELINT INTL. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Device is a Safety Hypodermic Syringe for injection of medicine to patients. This device aids in the prevention of needlestick injuries.
    Device Description
    Not Found
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    K Number
    K031500
    Device Name
    EXCEL PRIMARY SOLUTION SET
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2003-07-25

    (73 days)

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

    EXELINT INTL. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Primary Solution set is used for infusion of I.V. solutions and/or medication to a patient intravenously. This safety feature may aid in the prevention of needle stick injury.
    Device Description
    Not Found
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    K Number
    K011754
    Device Name
    EXEL SECURETOUCH PTP SYRINGE
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2003-01-22

    (595 days)

    Product Code
    MEG, FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXELINT INTL. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS DEVICE IS A SAFETY HYPODERMIC SYRINGE FOR INJECTION OF MEDICATION TO PATIENTS. =THIS DEVICE AIDS IN PREVENTION OF NEEDLE STICK INJURIES=
    Device Description
    EXEL SECURE TOUCH SAFETY SYRINGE
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    K Number
    K020533
    Device Name
    EXEL VACULET BLOOD COLLECTION SET
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2002-12-02

    (286 days)

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

    EXELINT INTL. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is an integral part of blood collection (intravenously) used in connection with luer adapter for collection of whole blood into tubes.
    Device Description
    Not Found
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    K Number
    K022406
    Device Name
    EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2002-09-30

    (69 days)

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

    EXELINT INTL. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended to be used to collect blood for various blood tests. The EXELINT SecureTouch Vaculet Safety Blood Collection Set aids in the prevention of accidental needle stick injuries.
    Device Description
    EXEL Secure Touch Safety Vaculet Blood Collection Set
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    K Number
    K011757
    Device Name
    EXEL COMFORTPOINT INSULIN PEN NEEDLE
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2002-01-23

    (231 days)

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

    EXELINT INTL. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS DEVICE IS USED FOR INJECTIONOF INSULIN VIA PEN NEEDLE/DEVICE FOR USE BY DIABETIC PATIENTS .
    Device Description
    Not Found
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    K Number
    K012879
    Device Name
    EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2002-01-17

    (142 days)

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

    EXELINT INTL. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Huber Infusion Sets are used for infusion of medication to a patient. This particular device is used for Oncology/Chemotherapy treatment.
    Device Description
    Huber Infusion Set with Needleless Injection Site
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    K Number
    K013037
    Device Name
    EXCEL A.V FISUTAL NEEDLE SET
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2001-12-07

    (88 days)

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

    EXELINT INTL. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS DEVICE IS AN A.V. FISTULA NEEDLE SET PART OF EXTRACORPORIAL ARTICICAL IS THE FOR SYSTEM FOR THE TREATHENTS WITH RENAL PALLURE TO PROVIDE ACCESS TO THE PATIENT'S BLOOD VESSEL FOR HEMODIALYSIS.
    Device Description
    EXEL A.V. FISTULA NEEDLE SET
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    K Number
    K011405
    Device Name
    EXEL INJECTION PLUG WITH CAP
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2001-09-27

    (142 days)

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

    EXELINT INTL. CO.

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

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