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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K213494
Device Name Aveir Retrieval Catheter
Applicant
Abbott Medical
15900 Valley View Court
Sylmar,  CA  91342
Applicant Contact Bijal Jain
Correspondent
Abbott Medical
15900 Valley View Court
Sylmar,  CA  91342
Correspondent Contact Bijal Jain
Regulation Number870.5150
Classification Product Code
MMX  
Date Received11/01/2021
Decision Date 04/01/2022
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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