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510(k) Data Aggregation

    K Number
    K053021
    Device Name
    ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
    Manufacturer
    ESTECH, INC.
    Date Cleared
    2006-01-26

    (92 days)

    Product Code
    DTS
    Regulation Number
    870.4420
    Why did this record match?
    Product Code :

    DTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTECH Clearview™ MV Atrial Depressor is intended to remove excess fluids from the surgical field for filtering and return to the patient during cardiopulmonary bypass of up to 6 hours. It can also be used to retract tissue to increase visibility.
    Device Description
    The Estech Clearview™ MV Atrial Depressor is a sterile, single use, surgical instruments intended for the collection of blood and other fluids from the surgical field for return through the cardiotomy system during open heart surgery. The a molded polymer proximal connector is intended to connect into cardiopulmonary bypass system to return blood and fluids into the extracorporeal circulation circuit, most typically during stoppedheart surgical procedures. The Estech Clearview™ MV Atrial Depressor has an integrated shaft designed to connect to the Estech Small Incision Retractor. The retractor creates access to the surgical field via thoracotomy or mini-sternotomy. When mounted to the retractor, the Estech Clearview™ MV Atrial Depressor can also be used to retract tissues while collecting fluids.
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    K Number
    K982891
    Device Name
    CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
    Manufacturer
    CALIFORNIA MEDICAL LABORATORIES, INC.
    Date Cleared
    1998-09-30

    (44 days)

    Product Code
    DTS
    Regulation Number
    870.4420
    Why did this record match?
    Product Code :

    DTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field. The Standard and Small Rigid Tip Suction Wands are indicated for use to remove excess fluid from the surgical field.
    Device Description
    The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field. The Standard Rigid Tip Suction Wand consists of an angled Stainless Steel suction wand bonded to a rigid, fluted style suction tip at the distal end and a ¼" barbed connector at the proximal end both of which are made of ABS. The stainless steel wand has a lightweight plastic handle made of medical grade ABS material. The Small Rigid Tip Suction Wand is manufactured in a similar manner and consisting of the same materials as the Standard Rigid Tip Suction Wand.
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    K Number
    K963756
    Device Name
    IBC CARDIAC SUCTION WARD
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORP.
    Date Cleared
    1997-11-14

    (423 days)

    Product Code
    DTS
    Regulation Number
    870.4420
    Why did this record match?
    Product Code :

    DTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBC Cardiac Suction Wand is intended for use by a Cardiac Surgeon during open heart surgery for the collection of blood and other fluids from the sterile surgical field for filtering and return to the patient via the Cardiotomy line. It is also intended for use by surgeons for the removal of waste fluids from the surgical field.
    Device Description
    The IBC Cardiac Suction Wand is a single use, sterile, disposable surgical instrument intended for the collection of blood and other fluids from the surgical field for return the cardiotomy system during open heart surgery.
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