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510(k) Data Aggregation

    K Number
    K122306
    Device Name
    SYNOVIS COLLAGEN MATRIX (TBD)
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Date Cleared
    2013-03-08

    (219 days)

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

    SYNOVIS SURGICAL INNOVATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.
    Device Description
    Synovis Collagen Matrix is an implantable biologic patch comprised of non-crosslinked bovine pericardium.
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    K Number
    K083039
    Device Name
    VERITAS COLLAGEN MATRIX (DRY)
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Date Cleared
    2008-11-26

    (43 days)

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

    SYNOVIS SURGICAL INNOVATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Veritas Collagen Matrix (Dry) is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed. Veritas Collagen Matrix (Dry) can be used for reinforcement of staple lines during lung and bronchus resection, during gastric, bariatric, small bowel, mesentery, colon and colorectal procedures, and cardiac surgery (for example, occlusion of the left atrial appendage during open chest procedures. Veritas Collagen Matrix (Dry) minimizes tissue attachment to the device in case of direct contact with viscera.
    Device Description
    Veritas Collagen Matrix is an implantable surgical mesh comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix bovine pericardium is procured in the United States from cattle less than 30 months of age. Veritas Collagen Matrix allows for neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling. Veritas Collagen Matrix also minimizes tissue attachment to the device in case of direct contact with viscera.
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    K Number
    K062915
    Device Name
    VERITAS COLLAGEN MATRIX
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Date Cleared
    2006-12-06

    (70 days)

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

    SYNOVIS SURGICAL INNOVATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following: Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus. Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical). Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.
    Device Description
    An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas® Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.
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    K Number
    K041669
    Device Name
    VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Date Cleared
    2004-10-27

    (128 days)

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

    SYNOVIS SURGICAL INNOVATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Veritas Dry Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed. Veritas Dry can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures. Veritas Dry can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures. Veritas Dry is intended to be used for reinforcement of suture-lines and staple-lines (for example: occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
    Device Description
    Veritas Dry is intended to be used as a staple line buttress. Veritas Dry is composed of dehydrated non-crosslinked bovine pericardium, to facilitate easy loading of the pericardium strips onto the stapler forks, an anvil and a cartridge strip are secured in a mounting unit. One mounting unit is used for each stapler firing. Each Veritas Dry unit is provided sterile in a double pouch.
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    K Number
    K040415
    Device Name
    PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Date Cleared
    2004-04-14

    (56 days)

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

    SYNOVIS SURGICAL INNOVATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed. Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures. Peri-Strips can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures. Peri-Strips is intended to be used for reinforcement of suturelines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
    Device Description
    An implantable surgical patch comprised of crosslinked bovine pericardium
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    K Number
    K040119
    Device Name
    PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Date Cleared
    2004-03-17

    (57 days)

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

    SYNOVIS SURGICAL INNOVATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed. Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures. Peri-Strips can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
    Device Description
    An implantable surgical patch comprised of crosslinked bovine pericardium
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    K Number
    K040001
    Device Name
    STEERABLE STYLET
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Date Cleared
    2004-03-09

    (67 days)

    Product Code
    DRB
    Regulation Number
    870.1380
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNOVIS SURGICAL INNOVATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.
    Device Description
    The Steerable Stylet is a sterile, single-use, disposable implantation tool which assists defining and varying the curvature of the distal portion of the pacemaker lead during implantation.
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    K Number
    K030879
    Device Name
    VERITAS COLLAGEN MATRIX
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Date Cleared
    2003-04-24

    (35 days)

    Product Code
    OXE, FTM, OWV, OXB, PAJ
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNOVIS SURGICAL INNOVATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following: > Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection. segmentectomy, pnuemonectomy/pneumectomy, pneumoreduction) and other incision and excision of the lung and bronchus. > Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. > Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).
    Device Description
    An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neovascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.
    Ask a Question

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