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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K234034
Device Name VenaCore Thrombectomy Catheter (46-101)
Applicant
Inari Medical, Inc.
6001 Oak Canyon
Suite 100
Irvine,  CA  92618
Applicant Contact Kaitlyn Weinkauf
Correspondent
Inari Medical, Inc.
6001 Oak Canyon
Suite 100
Irvine,  CA  92618
Correspondent Contact Kaitlyn Weinkauf
Regulation Number870.5150
Classification Product Code
QEW  
Date Received12/20/2023
Decision Date 02/09/2024
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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