510(k) K200871

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator by Control Medical Technology — Product Code QEZ

K200871 is an FDA 510(k) premarket notification submitted by Control Medical Technology for the device "Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator". The FDA issued a decision of Substantially Equivalent on May 4, 2020. The device falls under product code QEZ (Aspiration Thrombectomy Catheter), a Class II device regulated under 21 CFR 870.5150. Control Medical Technology has at least 3 other 510(k) clearances on record.