FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class II

FDA Device Classification

Classification Details

Product Code
FOZ
Device Class
Class II
Regulation Number
880.5200
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252398terumo medical products (hangzhou) coSURFLO Hybria Closed System Safety IV CatheterDecember 17, 2025
K252677poly medicure limitedPolyshield Safety IV CathetersNovember 5, 2025
K251422becton dickinson infusion therapy systemsBD Saf-T-Intima™ Subcutaneous Catheter SystemOctober 8, 2025
K243403becton dickinson infusion therapy systemsBD Nexiva™ Closed IV Catheter SystemJuly 25, 2025
K251155becton dickinson infusion therapy systemsBD Cathena™ Safety IV CatheterJuly 11, 2025
K251654becton dickinson infusion therapy systemsBD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IVJune 27, 2025
K250682becton dickinson infusion therapy systemsBD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ ClosedJune 3, 2025
K243105venocareRuby Intravascular CatheterMay 16, 2025
K250292skydance vascularOSPREY Midline Closed IV Catheter System (OspreyEDC-F20)May 2, 2025
K244059access vascularHydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F DualMarch 27, 2025
K243599arrow international, llc (a subsidiary of teleflex, inc.)Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)March 14, 2025
K242281arrow international, llc (a subsidiary of teleflex, inc.)Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow EndDecember 20, 2024
K241115spectrum vascularSV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter;November 27, 2024
K240359becton, dickinson and company (bard access systems, inc.)PowerGlide Pro™ Midline CatheterJuly 29, 2024
K241845b.braun medicalIntrocan Safety® 2 IV CatheterJuly 26, 2024
K233106bard access systems, inc. (c.r. bard, inc.)AccuCath Ace™ Intravascular CatheterApril 19, 2024
K232234poly medicure limitedNouvo Safety SetMarch 15, 2024
K233529becton dickinson infusion therapy systemsBD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConDecember 1, 2023
K231239becton dickinson infusion therapy systemsNexiva™ Closed IV Catheter System with NearPort™ IV AccessSeptember 22, 2023
K231401poly medicure limitedPolysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaSeptember 21, 2023