HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)

About This 510(k) Submission

K244059 is an FDA 510(k) clearance for the HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104), a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Access Vascular, Inc. (Billerica, US). The FDA issued a Cleared decision on March 27, 2025, 86 days after receiving the submission on December 31, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.