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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 K033742
Device Name BOSTON SCIENTIFIC V-18 CONTROL WIRE
Applicant
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact DEBORAH THOMAS
Correspondent
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact DEBORAH THOMAS
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/28/2003
Decision Date 01/12/2004
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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