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510(k) Data Aggregation

    K Number
    K200289
    Device Name
    Michler-Kapp Cardiovascular Vent Catheter
    Manufacturer
    Kapp Surgical Instrument, Inc.
    Date Cleared
    2021-01-28

    (358 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kapp Surgical Instrument, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Michler-Kapp Cardiovascular Vent Catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.
    Device Description
    This balloon-tipped left ventricular vent is intended to drain the left ventricle and left atrium of air, blood, and solid particles generated during surgery. The balloon-tipped IV vent is intended to be inserted through the open left atrium or through the right superior pulmonary vein and across the mitral valve into the left ventricle. In addition, it can be introduced directly into the left ventricle during mitral valve surgery. The design of the balloon-tipped LV vent focuses on ease of passage, position and safety. The soft balloon will inflate in the left ventricle, keeping the catheter tip below the mitral valve to ensure drair, debris and blood from the left ventricle. In addition, the proximal holes will drain air, particulate debris, and blood from the left atrium.
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    K Number
    K072216
    Device Name
    KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
    Manufacturer
    KAPP SURGICAL INSTRUMENT, INC.
    Date Cleared
    2007-11-09

    (92 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAPP SURGICAL INSTRUMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KAPP Bari-Ring Endoscopic Marker is intended to be used to radiographically (limited to x-ray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy).
    Device Description
    The KAPP Bari-Ring Endoscopic Marker consists of a nickel titanium stainless steel ring deployed during surgery. It is supplied non-sterile for single long term (30 day) use to mark the spot expected to require further surgery within 30 days. The ring is homogenously constructed of a ring of nickel titanium conforming to ASTM F 2063-05.
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    K Number
    K050384
    Device Name
    KAPP BARI-RING, MODEL KS-BR-2005
    Manufacturer
    KAPP SURGICAL INSTRUMENT, INC.
    Date Cleared
    2006-01-13

    (332 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAPP SURGICAL INSTRUMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KAPP Bari-Ring Endoscopic Marker is intended to radiographically (limited to xray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy).
    Device Description
    The KAPP Bari-Ring Endoscopic Marker consists of a stainless steel ring deployed during surgery supplied non-sterile for single long term use to radiographically (limited to x-ray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy).
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    K Number
    K050655
    Device Name
    MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005
    Manufacturer
    KAPP SURGICAL INSTRUMENT, INC.
    Date Cleared
    2005-08-08

    (147 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAPP SURGICAL INSTRUMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mondeal® RADIUS HO System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.
    Device Description
    The Mondeal® Radius Hand Osteosynthesis System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and left hand configurations.. Manual reusable surgical instruments are supplied to facilitate implantation
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    K Number
    K050657
    Device Name
    MONDEAL CONTOUR HO SYSTEM
    Manufacturer
    KAPP SURGICAL INSTRUMENT, INC.
    Date Cleared
    2005-08-08

    (147 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAPP SURGICAL INSTRUMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mondeal® CONTOUR HO System is intended to be used for the internal fixation of small bones including the hand and foot.
    Device Description
    Dorted Desert from Hand Osteosynthesis System consists of titanium plates with shapes and sizes designed for internal fixation of small bones including the hand and foot, and screws of varying lengths from 4 to 23 mm and 1.2 , 1.7, and 2.3 mm in diameter, supplied nonsterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include straight, "T" shaped and condylar configurations. Manual reusable surgical instruments are supplied to facilitate implantation
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    K Number
    K033930
    Device Name
    KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
    Manufacturer
    KAPP SURGICAL INSTRUMENT, INC.
    Date Cleared
    2004-07-28

    (223 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAPP SURGICAL INSTRUMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KAPP Patient Matched Ulnar Head Wrist Implant is intended to be used for: - Replacement of the distal radioulnar joint following ulnar head resection arthroplasty: - Replacement of the radial head for degenerative, rheumatoid, or post-traumatic disabilities presenting pain and weakness of the wrist joint and resistance to conservative treatment; - Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and - Failed ulnar head resection. It is intended for patient matched use with bone cement and or press-fit fixation.
    Device Description
    The Kapp Patient Matched Ulnar Head Wrist Implant includes various sizes of implants and accessory surgical instruments. The implant allows for replacement of the ulnar head.
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    K Number
    K030237
    Device Name
    KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
    Manufacturer
    KAPP SURGICAL INSTRUMENT, INC.
    Date Cleared
    2003-08-29

    (218 days)

    Product Code
    KWI
    Regulation Number
    888.3170
    Why did this record match?
    Applicant Name (Manufacturer) :

    KAPP SURGICAL INSTRUMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KAPP Custom Radial Elbow Implant is intended to be used for: replacement of the proximal end of the radius: Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and or proximal radio-ulnar joint with either joint destruction or subluxation visible on x-ray and or resistance to conservative treatment; primary replacement after fracture of the radial head; symptomatic sequelae after radial head resection; revision following failed radial head arthroplasty. It is intended for custom single use with bone cement.
    Device Description
    The Kapp Custom Radial Head Elbow Implant includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.
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