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510(k) Data Aggregation

    K Number
    K040641
    Device Name
    ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1
    Manufacturer
    EPICOR MEDICAL, INC.
    Date Cleared
    2004-05-05

    (56 days)

    Product Code
    NTB, OCL
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPICOR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery. The items in the UltraCinch Accessory Pack are intended for use in the ablation of cardiac tissue during cardiac surgery.
    Device Description
    Epicor Medical UltraCinch Tissue Ablation Device and Accessories
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    K Number
    K022894
    Device Name
    EPICOR MEDICAL ABLATION SYSTEM
    Manufacturer
    EPICOR MEDICAL, INC.
    Date Cleared
    2004-02-26

    (541 days)

    Product Code
    NTB, OCL
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPICOR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epicor Medical Ablation System (the UltraWand Ablation Device, Ablation Control System, and Connecting Cable) is Intended for the ablation of cardiac tissue during cardiac surgery.
    Device Description
    Epicor Medical Ablation System, including the UltraWand Ablation Device, Ablation Control System, and Connecting Cable
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