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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 K260028
Device Name CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister
Applicant
Argon Medical Devices, Inc.
1445 Flat Creek Rd.
Athens,  TX  75751
Applicant Contact Ana Jimenez-Hughes
Correspondent
Argon Medical Devices, Inc.
1445 Flat Creek Rd.
Athens,  TX  75751
Correspondent Contact Ana Jimenez-Hughes
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received01/05/2026
Decision Date 02/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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