510(k) K012544

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

K012544 is an FDA 510(k) premarket notification submitted by Vascular Architects, Inc. for the device "VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 15, 2001. 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.