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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 K180726
Device Name Savion DLVR Guidewire, Savion FLX Guidewire
Applicant
Boston Scientific, Inc.
Three Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Jake Baldauf
Correspondent
Boston Scientific, Inc.
Three Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Jake Baldauf
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/20/2018
Decision Date 06/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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