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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, ultrasound, intravascular
510(k) Number K111043
Device Name ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538 -6515
Applicant Contact JANICE E BROWN, RAC
Correspondent
BOSTON SCIENTIFIC CORP.
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538 -6515
Correspondent Contact JANICE E BROWN, RAC
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received04/15/2011
Decision Date 08/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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