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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 K163699
Device Name ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook
Applicant
Aln Implants Chirurgicaux
589 Chemin Du Niel
Bormes Les Mimosas,  FR 83230
Applicant Contact Alain Nigon
Correspondent
Aln Implants Chirurgicaux
589 Chemin Du Niel
Bormes Les Mimosas,  FR 83230
Correspondent Contact Jagoda Rewers
Regulation Number870.3375
Classification Product Code
DTK  
Date Received12/29/2016
Decision Date 09/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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