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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 K063312
Device Name MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
Applicant
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact ROBERT Z PHILLIPS
Correspondent
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact ROBERT Z PHILLIPS
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
ITX  
Date Received11/02/2006
Decision Date 11/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
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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