510(k) K003173

ASPIRE COVERED STENT AND DELIVERY CATHETER by Vascular Architects, Inc. — Product Code ESW

K003173 is an FDA 510(k) premarket notification submitted by Vascular Architects, Inc. for the device "ASPIRE COVERED STENT AND DELIVERY CATHETER". The FDA issued a decision of Substantially Equivalent on March 13, 2001. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Vascular Architects, Inc. has at least 4 other 510(k) clearances on record.