510(k) K030567

MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM by Vascular Architects, Inc. — Product Code JCT

K030567 is an FDA 510(k) premarket notification submitted by Vascular Architects, Inc. for the device "MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 24, 2003. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Vascular Architects, Inc. has at least 4 other 510(k) clearances on record.