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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K003173
Device Name ASPIRE COVERED STENT AND DELIVERY CATHETER
Applicant
Vascular Architects, Inc.
1830 Bering Dr.
San Jose,  CA  95112
Applicant Contact KEVIN F MACDONALD
Correspondent
Vascular Architects, Inc.
1830 Bering Dr.
San Jose,  CA  95112
Correspondent Contact KEVIN F MACDONALD
Regulation Number878.3610
Classification Product Code
ESW  
Date Received10/10/2000
Decision Date 03/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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