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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K984627
Device Name AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
Applicant
ARTERIAL VASCULAR ENGINEERING, INC.
129 CONCORD RD.
BILLERICA,  MA  01821
Applicant Contact DEBORAH L HERRINGTON
Correspondent
ARTERIAL VASCULAR ENGINEERING, INC.
129 CONCORD RD.
BILLERICA,  MA  01821
Correspondent Contact DEBORAH L HERRINGTON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/30/1998
Decision Date 07/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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