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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
Admedus Regen Pty Ltd
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
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?
Applicant Name (Manufacturer) :
Admedus Regen Pty Ltd
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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K Number
K162579Device Name
VascuCel
Manufacturer
Admedus Regen Pty Ltd
Date Cleared
2016-10-14
(29 days)
Product Code
DXZ
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
Admedus Regen Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VascuCel is indicated as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing.
Device Description
The VascuCel 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 2 x 8 cm size and a 0.8 x 8 cm size.
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