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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 K152605
Device Name Impulse Angiographic Catheter, Expo Angiographic Catheter
Applicant
BOSTON SCIENTIFIC CORPORATION
One Scimed Place
Maple Grove,  MN  55311
Applicant Contact MAC MCKEEN
Correspondent
BOSTON SCIENTIFIC CORPORATION
One Scimed Place
Maple Grove,  MN  55311
Correspondent Contact MAC MCKEEN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/11/2015
Decision Date 10/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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