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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K242520
Device Name Element Vascular Access System
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Applicant Contact Soltanzadeh Sindokht (Sisi)
Correspondent
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Correspondent Contact Soltanzadeh Sindokht (Sisi)
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/23/2024
Decision Date 11/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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