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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 K123765
Device Name GUIDEZILLA GUIDE EXTENSION CATHETER
Applicant
Boston Scientific
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact HOLLY RAMIREZ
Correspondent
Boston Scientific
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact HOLLY RAMIREZ
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/07/2012
Decision Date 03/19/2013
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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