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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.
Freemont,  CA  94538
Applicant Contact GEORGE J PRENDERGAST
Correspondent
Boston Scientific, Target
47900 Bayside Pkwy.
Freemont,  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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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