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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 K182315
Device Name Magic Torque DLVR Guidewire
Applicant
Boston Scientific Corporation
3 Scimed Place
Maple Grove,  MN  55311
Applicant Contact Andrea Dance
Correspondent
Boston Scientific Corporation
3 Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Andrea Dance
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/27/2018
Decision Date 09/26/2018
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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