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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K100892
Device Name RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
Applicant
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Scott Sepple
Correspondent
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Scott Sepple
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/31/2010
Decision Date 04/12/2010
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
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