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510(k) Data Aggregation

    K Number
    K021938
    Device Name
    VITALCARE URETHRAL CATHETER
    Manufacturer
    Date Cleared
    2003-04-22

    (314 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VitalCare's Urethral Catheters are intended to be inserted through the urethra to the bladder and utilized for passage of fluid from/to the urinary tract.
    Device Description
    Urological Urethral Catheter
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    K Number
    K021939
    Device Name
    VITALCARE FOLEY CATHETER
    Manufacturer
    Date Cleared
    2003-04-22

    (314 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VitalCare's Foley Catheters are intended to be inserted through the urethra to the bladder and utilized for passage of fluid from /to the urinary tract.
    Device Description
    Urological Foley Catheter
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    K Number
    K023872
    Device Name
    VITALCARE URETHRAL CATHETER RED RUBBER
    Manufacturer
    Date Cleared
    2003-04-10

    (141 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VitalCare's Urethral Catheter Red Rubber is intended to be inserted through the urethra to the bladder and utilized for passage of fluid from the urinary tract.
    Device Description
    Urethral Catheter Red Rubber
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