Clearance Summary
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) received FDA 510(k) clearance under submission number K244059, sponsored by Access Vascular, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-03-27.
- Submission: K244059
- Applicant / Sponsor: Access Vascular, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2025-03-27
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.