510(k) K103347

CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES by Intervascular Sas — Product Code DSY

K103347 is an FDA 510(k) premarket notification submitted by Intervascular Sas for the device "CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES". The FDA issued a decision of Substantially Equivalent on Feb 2, 2011. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. Intervascular Sas has at least 10 other 510(k) clearances on record.