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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K111485
Device Name FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
Applicant
Boston Scientific Corporation
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact ERIC ELLIOTT
Correspondent
Boston Scientific Corporation
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact ERIC ELLIOTT
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/31/2011
Decision Date 06/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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