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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 K011664
Device Name IMAGER II ANGIOGRAPHIC CATHETER
Applicant
Boston Scientific/Medi-Tech
One Boston Scientific Pl.
Natick,,  MA  01760
Applicant Contact JODI L GREENIZEN
Correspondent
Boston Scientific/Medi-Tech
One Boston Scientific Pl.
Natick,,  MA  01760
Correspondent Contact JODI L GREENIZEN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/30/2001
Decision Date 09/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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