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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 K010707
Device Name ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
Applicant
Boston Scientific, Target
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact IRENE JAWORSKI
Correspondent
Boston Scientific, Target
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact IRENE JAWORSKI
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
ITX  
Date Received03/09/2001
Decision Date 03/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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