FDA 510(k) Applications for Medical Device Product Code "MAL"
(Graft, Vascular, Synthetic/Biologic Composite)

FDA 510(k) Number Applicant Device Name Decision Date
K052302 BOSTON SCIENTIFIC CORP. HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION 09/12/2005
K021213 BOSTON SCIENTIFIC CORP. MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS 04/19/2002
K093231 LEMAITRE VASCULAR, INC. ALBOGRAFT VASCULAR PROSTHESIS 01/14/2010
K103080 LEMAITRE VASCULAR, INC. ALBOGRAFT VASCULAR PROSTHESIS 01/19/2011
K122612 MAQUET CARDIOVASCULAR, LLC HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX 09/10/2012
K954848 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT 02/01/1996


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