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510(k) Data Aggregation

    K Number
    K990142
    Device Name
    HT, MODEL HT PB
    Manufacturer
    SULZER OSCOR, INC.
    Date Cleared
    1999-07-30

    (192 days)

    Product Code
    DTB
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER OSCOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The tined passive tip permanent lead is indicated for ventricular placement. The lead is used in conjunction with an implantable pulse generator. A variety of pulse generators can be used in combination with the lead. The lead will connect directly to many commercially available pulse generators. Some pulse generators require the use of a commercially available adapter to make the connection to the lead.
    Device Description
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    K Number
    K970497
    Device Name
    PACE 101H
    Manufacturer
    SULZER OSCOR, INC.
    Date Cleared
    1997-06-04

    (114 days)

    Product Code
    DTE, 74D
    Regulation Number
    870.3600
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER OSCOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The external pacemaker PACE 101 H is designed for temporary stimulation of the heart in case of rhythm disturbances and conduction defects. According to present clinical experience, the instrument is especially suited for stimulation of the heart in the following cases: - treatment of patients before an operation, whereby an implantable pacemaker is . being inserted; - treatment of tachyarrhythmia; ♥ - treatment of special cases of acute myocardial infarction; . - treatment of patients after heart surgery.
    Device Description
    Not Found
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