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510(k) Data Aggregation

    K Number
    K221029
    Device Name
    PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
    Manufacturer
    Synovis Life Technologies, Inc.
    Date Cleared
    2022-10-19

    (195 days)

    Product Code
    PSQ
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    PSQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing. SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.
    Device Description
    PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is crosslinked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25°C (68-77°F). PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile. PERI-GUARD and SUPPLE PERI-GUARD are MR Safe. PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.
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    K Number
    K221032
    Device Name
    Vascu-Guard Vascular Repair Patch
    Manufacturer
    Synovis Life Technologies, Inc.
    Date Cleared
    2022-10-19

    (195 days)

    Product Code
    PSQ
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    PSQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VASCU-GUARD Vascular Repair Patch is used in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial vessels and arteriovenous access revisions.
    Device Description
    VASCU-GUARD Vascular Repair Patch (VASCU-GUARD) is derived from bovine pericardium procured from cattle originating in the United States. The pericardium is cross-linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25° (68-77°F). VASCU-GUARD is terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile. VASCU-GUARD is MR Safe. VASCU-GUARD utilizes animal tissue; patient must be informed prior to any procedure.
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    K Number
    K210331
    Device Name
    CardiaMend Pericardial and Epicardial Reconstruction Matrix
    Manufacturer
    Helios Cardio Inc.
    Date Cleared
    2021-12-21

    (319 days)

    Product Code
    PSQ, PSO
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    PSQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is intended for pericardial reconstruction and repair and for epicardial support and repair.
    Device Description
    CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is a porous acellular matrix derived from fetal bovine dermis designed to provide soft tissue reinforcement, repair, and reconstruction. The single-layer (1 ply) device is not chemically crosslinked and consists of a naturally woven network of collagen fibers. The single use device is supplied terminally sterilized via ethylene oxide and is available in a variety of sizes to be trimmed by the physician to meet individual patient needs.
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    K Number
    K190882
    Device Name
    XenoSure Biologic Patch
    Manufacturer
    LeMaitre Vascular
    Date Cleared
    2020-02-13

    (315 days)

    Product Code
    PSQ, FTM, MFX
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    PSQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.
    Device Description
    The XenoSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. XenoSure patch is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution.
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    K Number
    K191734
    Device Name
    MatriStem UBM Pericardial Patch
    Manufacturer
    Acell, Inc.
    Date Cleared
    2019-11-22

    (147 days)

    Product Code
    PSQ
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    PSQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MatriStem UBM™ Pericardial Patch is intended for the reconstruction and repair of the pericardium.
    Device Description
    The MatriStem UBM Pericardial Patch is a 4-layer multi-laminate device comprised of stacked urinary bladder matrix (UBM) sheets. The Pericardial Patch serves as a patch to reconstruct the pericardium and restore the native anatomy. The Pericardial Patch is available in three sizes: 7x10 cm, 7x15 cm, and 10x15 cm. Each device is packaged in a double peel-open pouch and an outer carton. The device is terminally sterilized using electron-beam irradiation.
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    K Number
    K183635
    Device Name
    PhotoFix Decellularized Bovine Pericardium
    Manufacturer
    CryoLife, Inc.
    Date Cleared
    2019-02-14

    (50 days)

    Product Code
    PSQ, PSO
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    PSQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).
    Device Description
    The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch that is prepared from bovine pericardium, stabilized using dye-mediated photooxidation, processed using ethylene oxide, and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes. PhotoFix is intended for single use only and cannot be resterilized. PhotoFix is supplied sterile in a sealed container with 22% buffered ethanol solution. Rinsing of the pericardium prior to implantation is not required.
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    K Number
    K181038
    Device Name
    CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
    Manufacturer
    CorMatrix Cardiovascular, Inc.
    Date Cleared
    2018-10-10

    (174 days)

    Product Code
    PSQ, PSO
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    PSQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CorMatrix(R) Cor Patch is intended for epicardial tissue support and repair.
    Device Description
    CorMatrix Cor Patch is intended for epicardial tissue support and repair. CorMatrix Cor Patch is derived from the same multi-laminate SIS-ECM material as the CorMatrix Tyke (2-ply, non-pressed). The CorMatrix® Cor Patch will be supplied as a 4-ply, lyophilized, sterilized sheet of SIS-ECM. With the exception of the differing layer counts and a change to the manufacturing process for the Cor Patch which does not result in a change to the fundamental technology of the device, the device design and construction are identical to the FDA-cleared CorMatrix® Tyke™ (K152127).
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    K Number
    K172085
    Device Name
    PhotoFix Decellularized Bovine Pericardium
    Manufacturer
    CryoLife, Inc.
    Date Cleared
    2017-12-04

    (146 days)

    Product Code
    PSQ
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    PSQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).
    Device Description
    The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch that is prepared from bovine pericardium, stabilized using dye-mediated photooxidation, processed using ethylene oxide, and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes. PhotoFix is intended for single use only and cannot be resterilized. PhotoFix is supplied sterile in a sealed container with 22% buffered ethanol solution. Rinsing of the pericardium prior to implantation is not required.
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    K Number
    K172660
    Device Name
    Duravess bovine pericardial vascular patch
    Manufacturer
    Edwards Lifesciences, LLC
    Date Cleared
    2017-11-17

    (73 days)

    Product Code
    PSQ, PSO
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    PSQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bovine pericardial vascular patch is intended for use as a surgical patch material for: vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; and suture-line buttressing.
    Device Description
    The pericardial patch is comprised of a piece of bovine pericardium that has been preserved in a phosphate buffered glutaraldehyde solution. The Duravess patch comes in three sizes and configurations for vascular reconstruction and repair purposes. Model DP08X8: 0.8 cm x 8 cm, rectangular with round corners and a tapered end Model DP1X6: 1 cm x 6 cm, rectangular with round corners Model DP2X9: 2 cm x 9 cm, rectangular with round corners
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    K Number
    K170951
    Device Name
    CardioCel 3D
    Manufacturer
    Admedus Regen Pty Ltd
    Date Cleared
    2017-04-28

    (28 days)

    Product Code
    PSQ
    Regulation Number
    870.3470
    Why did this record match?
    Product Code :

    PSQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CardioCel 3D is indicated for use as a patch in pericardial closure and the repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
    Device Description
    The CardioCel 3D device is a bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. It is offered in a 4 x 6 cm size with a 60° curve.
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