510(k) K223176

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 by Argon Medical Devices, Inc. — Product Code KRA

K223176 is an FDA 510(k) premarket notification submitted by Argon Medical Devices, Inc. for the device "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". The FDA issued a decision of Substantially Equivalent on April 10, 2023. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Argon Medical Devices, Inc. has at least 10 other 510(k) clearances on record.