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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K212199
Device Name ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
Applicant
Merit Medical Systems, Inc.
1600w Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact Kirk McIntosh
Correspondent
Merit Medical Systems, Inc.
1600w Merit Pkwy.
South Jordan,  UT  84095
Correspondent Contact Kirk McIntosh
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received07/14/2021
Decision Date 11/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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