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

About This 510(k) Submission

K223176 is an FDA 510(k) clearance for the 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, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on April 10, 2023, 181 days after receiving the submission on October 11, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.