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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K163314
Device Name Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter
Applicant
Boston Scientific Corporation
Two Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Nikki Wahlberg
Correspondent
Boston Scientific Corporation
Two Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Nikki Wahlberg
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/23/2016
Decision Date 03/23/2017
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
Recalls CDRH Recalls
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