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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Graft, Vascular, Synthetic/Biologic Composite
510(k) Number K093231
Device Name ALBOGRAFT VASCULAR PROSTHESIS
Applicant
LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON,  MA  01803
Applicant Contact ERIN DALY
Correspondent
LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON,  MA  01803
Correspondent Contact ERIN DALY
Regulation Number870.3450
Classification Product Code
MAL  
Date Received10/14/2009
Decision Date 01/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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