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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 K111498
Device Name FATHOM (TM) 14 STEERABLE GUIDEWIRE
Applicant
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact ERIC ELLIOTT
Correspondent
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
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
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