510(k) K233975

Zoom 6F Insert Catheters by Imperative Care, Inc. — Product Code DQO

K233975 is an FDA 510(k) premarket notification submitted by Imperative Care, Inc. for the device "Zoom 6F Insert Catheters". The FDA issued a decision of Substantially Equivalent on April 2, 2024. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Imperative Care, Inc. has at least 10 other 510(k) clearances on record.