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Found 10 results
510(k) Data Aggregation
K Number
K221029Device 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
870.3470Why 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
K221032Device Name
Vascu-Guard Vascular Repair Patch
Manufacturer
Synovis Life Technologies, Inc.
Date Cleared
2022-10-19
(195 days)
Product Code
PSQ
Regulation Number
870.3470Why 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
K210331Device Name
CardiaMend Pericardial and Epicardial Reconstruction Matrix
Manufacturer
Helios Cardio Inc.
Date Cleared
2021-12-21
(319 days)
Product Code
PSQ, PSO
Regulation Number
870.3470Why 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
K190882Device Name
XenoSure Biologic Patch
Manufacturer
LeMaitre Vascular
Date Cleared
2020-02-13
(315 days)
Product Code
PSQ, FTM, MFX
Regulation Number
870.3470Why 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
K191734Device Name
MatriStem UBM Pericardial Patch
Manufacturer
Acell, Inc.
Date Cleared
2019-11-22
(147 days)
Product Code
PSQ
Regulation Number
870.3470Why 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
K183635Device Name
PhotoFix Decellularized Bovine Pericardium
Manufacturer
CryoLife, Inc.
Date Cleared
2019-02-14
(50 days)
Product Code
PSQ, PSO
Regulation Number
870.3470Why 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
K181038Device 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
870.3470Why 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
K172085Device Name
PhotoFix Decellularized Bovine Pericardium
Manufacturer
CryoLife, Inc.
Date Cleared
2017-12-04
(146 days)
Product Code
PSQ
Regulation Number
870.3470Why 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
K172660Device Name
Duravess bovine pericardial vascular patch
Manufacturer
Edwards Lifesciences, LLC
Date Cleared
2017-11-17
(73 days)
Product Code
PSQ, PSO
Regulation Number
870.3470Why 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
K170951Device Name
CardioCel 3D
Manufacturer
Admedus Regen Pty Ltd
Date Cleared
2017-04-28
(28 days)
Product Code
PSQ
Regulation Number
870.3470Why 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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