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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K013789
Device Name EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
Applicant
BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT,  CA  94538
Applicant Contact GEORGE J PRENDERGAST
Correspondent
BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT,  CA  94538
Correspondent Contact GEORGE J PRENDERGAST
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/14/2001
Decision Date 12/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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