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510(k) Data Aggregation

    K Number
    K990308
    Device Name
    ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
    Date Cleared
    1999-12-10

    (312 days)

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

    ROCAP DIV. OF SABRATEK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ROCAP Heparin Flush Syringe 100 U/mL is indicated for use to maintain patency of indwelling venous access devices.
    Device Description
    Not Found
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    K Number
    K990390
    Device Name
    HEPARIN IV FLUSH SYRINGE, 10 U/ML \
    Date Cleared
    1999-12-10

    (304 days)

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

    ROCAP DIV. OF SABRATEK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ROCAP Heparin Flush Syringe 10 U/mL is indicated for use to maintain patency of indwelling venous access devices.
    Device Description
    Heparin Flush Syringe, 10 U/mL
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    K Number
    K984614
    Device Name
    NORMAL SALINE FLUSH SYRINGE
    Date Cleared
    1999-05-27

    (149 days)

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

    ROCAP DIV. OF SABRATEK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ROCAP Normal Saline Flush Syringe is indicated for use to maintain patency of indwelling venous access devices.
    Device Description
    Not Found
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