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510(k) Data Aggregation

    K Number
    K032893
    Device Name
    SHELHIGH NO-REACT BIOCUFF
    Manufacturer
    SHELHIGH, INC.
    Date Cleared
    2003-12-19

    (93 days)

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

    SHELHIGH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EnCuff is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a non resorbable scaffold to assist with a soft tissue repair. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, to the supraspinatus, during rotator cuff repair surgery.
    Device Description
    The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process. The device is provided sterile in 2% benzyl alcohol solution.
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    K Number
    K023940
    Device Name
    SHELHIGH BIORING
    Manufacturer
    SHELHIGH, INC.
    Date Cleared
    2003-06-04

    (190 days)

    Product Code
    KRH
    Regulation Number
    870.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHELHIGH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shelhigh BioRing™ is intended for use in the repair of the human cardiac mitral valve. The Shelhigh BioRing™ is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or a replacement for a previously implanted annuloplasty ring.
    Device Description
    The Shelhigh BioRing™ consists of circular rings made of Polyester material and covered with No-React processed pericardium.
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    K Number
    K982101
    Device Name
    SHELHIGH NO-REACT DURA SHIELD
    Manufacturer
    SHELHIGH, INC.
    Date Cleared
    2000-05-02

    (687 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHELHIGH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.
    Device Description
    The Shelhigh No-React® dura Substitute is a glutaraldehyde fixed sheet of bovine pericardium.rinsed with the detoxification process No-React®. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant.
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    K Number
    K991567
    Device Name
    SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
    Manufacturer
    SHELHIGH, INC.
    Date Cleared
    1999-07-14

    (70 days)

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

    SHELHIGH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tissue repair patch, for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding , rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias, or defects of the diaphragm, femoral, incisional, inguinal, lumbar, and umbilical hernia.
    Device Description
    The Shelhigh No-React® Tissue repair patch/ UroPatch™ is made of glutaraldehyde fixed boyine pericardium. rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
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    K Number
    K982810
    Device Name
    SHELHIGH NO-REACT VASCUPATCH
    Manufacturer
    SHELHIGH, INC.
    Date Cleared
    1998-10-28

    (78 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHELHIGH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For repair of carotid endarterectomy and vascular patch grafting.
    Device Description
    The Shelhigh No-React® VascuPatch™ is a made of glutaraldehyde fixed bovine pericardium, rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
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    K Number
    K981756
    Device Name
    SHELHIGH NO-REACT PNEUMOPLEDGETS
    Manufacturer
    SHELHIGH, INC.
    Date Cleared
    1998-08-05

    (79 days)

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

    SHELHIGH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use to reinforced the soft tissue of the lung, thereby sealing or reducing air leak that occur during pulmonary surgery.
    Device Description
    The Shelhigh No-React® PneumoPledgets strips are glutaraldehyde fixed sheet of bovine pericardium. They are held on the stapler by a unique design of a loop on the anterior part of the PneumoPledgets. It holds the strip by inserting the pointed edge of the staple into the loop. The posterior part (if needed) is held by an "O" ring made of pericardium as well. The PneumoPledgets. strips are customized to fit all sizes and types of staples. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar. The material exhibits good tensile strength, shrink temperature excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
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    K Number
    K974914
    Device Name
    SHELHIGH NO-REACT PERICARDIAL PATCHES
    Manufacturer
    SHELHIGH, INC.
    Date Cleared
    1998-06-03

    (177 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHELHIGH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as a patch for closure of the patient's pericardium after open heart surgery, The patch may be tailored during surgery to meet the surgeon's needs. The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as an intracardiac patch for open heart surgery, as well as to close intercavitary defect, and enlarge the aortic root . The patch may be tailored during surgery to meet the surgeon's needs.
    Device Description
    The Shelhigh No-React® Pericardial patch is a glutaraldehyde fixed sheet of bovine pericardium, rinsed with the detoxification process No-React®. The device is provided sterile in benzyl alcohol solution. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant. The material exhibits excellent biocompatibility. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldhyde processed bovine pericardium has a long history of success as a permanently implanted material.
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    K Number
    K964467
    Device Name
    SHELHIGH PERICARDIAL PATCH
    Manufacturer
    SHELHIGH, INC.
    Date Cleared
    1997-09-23

    (320 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHELHIGH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shelhigh Pericardial Patch is intended for use as a pericardial patch, and as an intracardiac patch.
    Device Description
    Not Found
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