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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 K143563
FOIA Releasable 510(k) K143563
Device Name Infusion Aspiration Catheter System
Applicant
Inari Medical, Inc.
8 Argonaut
Suite 100
Aliso Viejo,  CA  92656
Applicant Contact Eben Gordon
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received12/16/2014
Decision Date 02/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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