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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stripper, Artery, Intraluminal
510(k) Number K003719
Device Name VASCULAR ARCHITECTS PERISCOPE DEVICE
Applicant
Vascular Architects, Inc.
1830 Bering Dr.
San Jose,  CA  95112
Applicant Contact JEAN M CAILLOUETTE
Correspondent
Vascular Architects, Inc.
1830 Bering Dr.
San Jose,  CA  95112
Correspondent Contact JEAN M CAILLOUETTE
Regulation Number870.4875
Classification Product Code
DWX  
Date Received12/04/2000
Decision Date 02/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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