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K Number
K130872Device Name
CARDIOCEL
Manufacturer
CELXCEL PTY LTD
Date Cleared
2014-01-30
(307 days)
Product Code
DXZ
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
CELXCEL PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CardioCel 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 device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut, flat sheet of acellular collagen. CardioCel has a shelf life of 24 months when stored between 2°C - 25°C. CardioCel is supplied in three sizes: 4 x 4 cm, 5 x 8 cm and 14 x 7 cm.
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