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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 K211875
Device Name Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
Applicant
William Cook Europe ApS
Sandet 6
Bjaeverskov,  DK 4632
Applicant Contact Mie Dyrholm
Correspondent
William Cook Europe ApS
Sandet 6
Bjaeverskov,  DK 4632
Correspondent Contact Mie Dyrholm
Regulation Number870.3375
Classification Product Code
DTK  
Date Received06/17/2021
Decision Date 07/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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