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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 K210190
Device Name ClotTriever Thrombectomy System
Applicant
Irani Medical, Inc.
9 Parker, Suite 100
Irvine,  CA  92618
Applicant Contact Larry Boucher
Correspondent
Irani Medical, Inc.
9 Parker, Suite 100
Irvine,  CA  92618
Correspondent Contact Larry Boucher
Regulation Number870.5150
Classification Product Code
QEW  
Date Received01/25/2021
Decision Date 02/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Clinical Trials NCT03575364
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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