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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 K042568
Device Name EXCELSIOR 1018 AND SL-10 MICROCATHETERS
Applicant
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact VICTOR HAM
Correspondent
Boston Scientific Corp
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact VICTOR HAM
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/21/2004
Decision Date 10/15/2004
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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