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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 K240578
Device Name VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
Applicant
B.Braun Medical, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact Tracy Larish
Correspondent
B.Braun Medical, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Tracy Larish
Regulation Number870.3375
Classification Product Code
DTK  
Date Received03/01/2024
Decision Date 07/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Clinical Trials NCT02381509
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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