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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 K060175
Device Name ISIGHT IMAGING CATHETER, MODEL 38986
Applicant
BOSTON SCIENTIFIC CORP.
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538
Applicant Contact ROBERT Z PHILLIPS
Correspondent
BOSTON SCIENTIFIC CORP.
47900 BAYSIDE PARKWAY
FREMONT,  CA  94538
Correspondent Contact ROBERT Z PHILLIPS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/23/2006
Decision Date 03/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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