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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Intravascular, Cardiovascular
510(k) Number K172557
Device Name Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
Applicant
William Cook Europe ApS
Sandet 6
Bjaeverskov,  DK 4632
Applicant Contact Henriette Stordal Christiansen
Correspondent
William Cook Europe ApS
Sandet 6
Bjaeverskov,  DK 4632
Correspondent Contact Henriette Stordal Christiansen
Regulation Number870.3375
Classification Product Code
DTK  
Date Received08/24/2017
Decision Date 11/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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