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510(k) Data Aggregation

    K Number
    K130131
    Device Name
    EDRAIN CHEST DRAINAGE SYSTEM
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2013-02-28

    (41 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Evacuate air and/or fluid from the chest cavity or mediastinum Help re-establish lung expansion and restore breathing dynamics Facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
    Device Description
    Not Found
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    K Number
    K122138
    Device Name
    ATRIUM FLIXENE IFG VASCULAR GRAFT
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2012-08-17

    (29 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atrium Graduated Wall Flixene IFG Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Device Description
    Atrium Graduated Wall Flixene IFG Graft
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    K Number
    K121070
    Device Name
    C-QUR RPM MESH
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2012-04-26

    (17 days)

    Product Code
    FTL, OXA
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Atrium C-QUR RPM Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.
    Device Description
    Not Found
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    K Number
    K113112
    Device Name
    CLEARWAY RX NB CATHETER
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2011-11-17

    (28 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearWay™ RX NB is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. It is not indicated for use in the neurovasculature.
    Device Description
    Not Found
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    K Number
    K102596
    Device Name
    ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2010-10-05

    (26 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atrium Graduated Wall Flixene Ax-Bifem Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Device Description
    Not Found
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    K Number
    K093431
    Device Name
    CLEARWAY OTW MODEL 85912
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2010-04-20

    (167 days)

    Product Code
    DQY, DOY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For localized infusion or irrigation of various diagnostic and therapeutic agents into the peripheral vasculature. It is not indicated for use in the neurovasculature.
    Device Description
    ClearWay OTW catheter
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    K Number
    K100076
    Device Name
    ATRIUM C-QUR OVT MESH
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2010-01-26

    (14 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atrium C-Qur TM OVT Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.
    Device Description
    The Atrium C-Qur" OVT Mesh is a surgical mesh used during surgical procedures. The mesh contains two layers of mesh stitched together. The second layer is cut into flaps. The intent of the addition of a second layer with flaps is to allow the surgeon to more easily position and attach the mesh to the surgical site.
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    K Number
    K090909
    Device Name
    C-QUR V -PATCH MESH
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2009-06-04

    (64 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Atrium C-QUR V-Patch™ Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.
    Device Description
    Not Found
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    K Number
    K082748
    Device Name
    ATRIUM PROLITE S MESH
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2009-01-14

    (117 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Atrium ProLite S Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.
    Device Description
    Not Found
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    K Number
    K081718
    Device Name
    EXPRESS CHEST DRAIN
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2008-07-25

    (37 days)

    Product Code
    KDQ
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
    Device Description
    Atrium Medical Corporation Express™ Chest Drain
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