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510(k) Data Aggregation
K Number
K240775Device Name
PeriBeam® Pericardial Membrane
Manufacturer
TamaBio
Date Cleared
2025-04-18
(393 days)
Product Code
DXZ
Regulation Number
870.3470Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PeriBeam® Pericardial Membrane is indicated for the reconstruction or repair of the pericardium.
Device Description
PeriBeam® is an ion-irradiated, expanded polytetrafluoroethylene (ePTFE) membrane used for reconstruction or repair of the pericardium. This device is intended for use as a temporary or permanent prosthesis for repair of pericardium
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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?
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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?
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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?
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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
K200955Device Name
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
Manufacturer
Vascutek Ltd
Date Cleared
2020-07-08
(90 days)
Product Code
DXZ
Regulation Number
870.3470Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vascutek Cardiovascular Fabric is indicated for vascular repair whenever knitted polyester fabrics are normally indicated.
Due to its particularly high strength. Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for endaterectorny, particularly of the carotid arteries.
Device Description
The Vascutek Cardiovascular Fabric are a range of gelatin sealed, knitted, polyester patch fabrics. The range consists of three different patch fabrics which are manufactured using identical materials, processes and procedures but which, because of slight differences in the pattern of the base fabric, exhibit different physical characteristics. This range of products is provided in order to give the implanting surgeon a choice of several different fabrics from which they can chose the most suitable according to their own preferences and according to specific demands of any given surgical situation.
Two of the patches, Gelseal™ and Gelsoft™, are based on fabrics which are currently used in Vascutek's range of tubular vascular prostheses, which have received Premarket approval from the FDA. The only difference between the cardiovascular fabrics and the tubular grafts is that the patches are produced in flat, patch formats (i.e. square or rectangular) and have not been subjected to the crimping process which is used in the production of the tubular prostheses. With this single exception, the manufacturing facilities, equipment, processes and the quality control processes and procedures are identical to those used in the manufacture of the Gelseal™ and Gelsoft™ vascular prostheses.
The third type of patch, the Thin Wall Carotid Patch, is also manufactured using the identical materials, processes and procedures as the other cardiovascular patches but with a slightly modified knit pattern. This new structure has been developed in order to maintain the physical characteristics necessary for general cardiovascular patching but with a reduced wall thickness and characteristics which make it ideally suited to use for parching carotid arteries after endarterectomy procedures.
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K Number
K200566Device Name
ADAPT Tissue
Manufacturer
Admedus Regen Pty Ltd
Date Cleared
2020-04-03
(30 days)
Product Code
DXZ, PSQ
Regulation Number
870.3470Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADAPT® Tissue is indicated for use as a patch in the repair of cardiac defects including intracardiac defects, septal defects, valve and annulus repair.
Device Description
The ADAPT® Tissue medical 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. The products range in size from 4cm² to 84cm² and can range in thickness from 0.25-0.80mm.
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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?
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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
K190884Device Name
TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
Manufacturer
Datascope Corp.
Date Cleared
2019-12-26
(266 days)
Product Code
GDW, FTL
Regulation Number
878.4750Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TigerPaw Pro is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
Device Description
The TigerPaw Pro is a flexible, implantable occlusion fastener to be placed on the ostium of the left atrial appendage (LAA) during open cardiac surgical procedures. TigerPaw Pro consists of a Fastener implant that is pre-loaded onto a Delivery Tool and is for single use only. It is designed to provide an alternative to conventional suture and surgical staplers for occlusion of the ostium of the LAA. The TigerPaw Pro implantable fastener comes in two lengths; 35mm and 45mm. Surgeon judgment based on patient anatomy should determine what length fastener to apply.
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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?
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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?
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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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