510(k) K031641

VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM by Vascular Architects, Inc. — Product Code JCT

K031641 is an FDA 510(k) premarket notification submitted by Vascular Architects, Inc. for the device "VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 1, 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.