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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 K061670
Device Name LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE
Applicant
William Cook Europe Aps
Sandet 6, Dk-4632
Bjaeverskov,  DK
Applicant Contact TINA H ANDERSON
Correspondent
William Cook Europe Aps
Sandet 6, Dk-4632
Bjaeverskov,  DK
Correspondent Contact TINA H ANDERSON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/14/2006
Decision Date 01/19/2007
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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