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510(k) Data Aggregation

    K Number
    K170726
    Device Name
    Biopsy Forceps
    Manufacturer
    Fehling Instruments GmbH & Co. KG
    Date Cleared
    2017-06-02

    (85 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Why did this record match?
    Product Code :

    DWZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FEHLING biopsy forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach.
    Device Description
    The Biopsy Forceps are designed to allow percutaneous access to the right or left ventricles of the heart to obtain diagnostic tissue samples. The forceps consist of three main components: - an actuating handle ergonomically designed for comfortable use, 1. - 2. a flexible shaft, - and surgical stainless steel cutting jaws. 3. At the distal end of the forceps is a pair of stainless steel jaws used to obtain the tissue samples. At the proximately end of the forceps is the actuation handle used to activate the jaws and steer the device. The product is provided single for use and sterile.
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    K Number
    K072051
    Device Name
    NOVATOME, MODEL: SU101-50
    Manufacturer
    SCHOLTEN SURGICAL INSTRUMENTS, INC.
    Date Cleared
    2007-10-03

    (69 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Why did this record match?
    Product Code :

    DWZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scholten Novatome™ is a surgical device used to perform endomyocardial biopsies.
    Device Description
    The Scholten Surgical Instruments, Inc. Novatome is a manually operated hand held surgical instrument designed to remove biopsy samples from the right or left ventricle of the Human Heart via percutaneous venous or arterial access. Specifically via the internal Jugular or subclavian veins or the femoral artery. The device consists of three main parts. The cutting jaws, a polymer coated flexible shaft, and an actuating handle. At the distal end of the forceps is a pair of jaws used to obtain the heart tissue samples. At the proximal end of the forceps is the actuation handle used to activate the jaws and steer the device. The device cutting jaws are single action in that one of the jaws is fixed and is attached to the end of the flexible shaft and the other jaw is movable and is attached to a link that is welded to the end of the actuation wire. The single moving jaw, the distance the jaws open, as well as the orientation of the jaw work in combination to control the amount of tissue obtained. The Novatome's actuation handle is made of an advanced high-performance polymer. The jaws, actuation wire, and other mechanical parts are made of stainless steel. The flexible shaft sheath material is Fluoropolymer tubing. The Novatome™ will be available in 9,8,7, and 6 French cutting jaw sizes, with flexible shaft lengths of 50, 70, and 100cm lengths.
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    K Number
    K010473
    Device Name
    SPARROWHAWK DISPOSABLE
    Manufacturer
    ATC TECHNOLOGIES, INC.
    Date Cleared
    2001-06-06

    (106 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Why did this record match?
    Product Code :

    DWZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000409
    Device Name
    MODIFICATION TO T-REX BIOPSY FORCEPS
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2000-02-28

    (20 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Why did this record match?
    Product Code :

    DWZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991486
    Device Name
    ULTRA-CBX
    Manufacturer
    MEDCANICA, INC.
    Date Cleared
    1999-11-05

    (191 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Why did this record match?
    Product Code :

    DWZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endomyocardial Biopsy Forceps are designed for endomyocardial biopsies.
    Device Description
    The EMB is sterile, single use, radiopaque, disposable device that is delivered non-toxic and non-pyrogenic. The device is transvascularly deployed to the right ventricle of the heart for the acquisition of endomyocardial tissue samples Typically, the approach is made from the jugular vein or femoral arteries. The EMB consists of 4 major components: the moveable handle, end-effectors (jaws), core wire, and sheath. The core wire is attached to the handle. Moving the handle opens and closes the jaws.
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    K Number
    K973818
    Device Name
    T-REX BIOPSY FORCEPS
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    1997-12-16

    (70 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Why did this record match?
    Product Code :

    DWZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-REX™ biopsy forceps are intended to obtain endomyocardial biopsy specimens. The specimens are taken for diagnosis of diseased heart tissue or for identification and monitoring of rejection factors in a transplanted heart.
    Device Description
    The T.REX™ forceps are designed to allow percutaneous access to the right or left ventricles of the heart in order to obtain diagnostic tissue samples. The forceps consist of three main components: a handle ergonomically designed for comfortable use, a body and surgical stainless steel cutting jaws.
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    K Number
    K974175
    Device Name
    HEARTPORT ENDOAORTIC CLAMP CATHETER
    Manufacturer
    HEARTPORT, INC.
    Date Cleared
    1997-12-16

    (40 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Why did this record match?
    Product Code :

    DWZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heartport Endoaortic Clamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
    Device Description
    The Heartport Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
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