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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K223176
Device Name Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister
Applicant
Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens,  TX  75751
Applicant Contact Ana Jimenez-Hughes
Correspondent
Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens,  TX  75751
Correspondent Contact Ana Jimenez-Hughes
Regulation Number870.1210
Classification Product Code
KRA  
Subsequent Product Code
QEW  
Date Received10/11/2022
Decision Date 04/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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