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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 K000956
Device Name MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
Applicant
Boston Scientific Scimed, Inc.
One Scimed Place
Maple Grove,  MN  55311
Applicant Contact MELANIE RASKA
Correspondent
Boston Scientific Scimed, Inc.
One Scimed Place
Maple Grove,  MN  55311
Correspondent Contact MELANIE RASKA
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/24/2000
Decision Date 04/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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