Product code FOZ

Current FDA Classification

Device name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Medical specialty
General Hospital
Device class
2
Regulation number
880.5200
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Ineligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.2026-05-15
K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2026-04-02
K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited2026-04-01
K252398SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd.2025-12-17
K252677Polyshield Safety IV CathetersPoly Medicure Limited2025-11-05
K251422BD Saf-T-Intima™ Subcutaneous Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2025-10-08
K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2025-07-25
K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2025-07-11
K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2025-06-27
K250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorBecton Dickinson Infusion Therapy Systems, Inc.2025-06-03
K243105Ruby Intravascular CatheterVenocare, Inc.2025-05-16
K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)Skydance Vascular, Inc.2025-05-02
K244059HydroMID 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)Access Vascular, Inc.2025-03-27
K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)Arrow International, LLC (A subsidiary of Teleflex, Inc.)2025-03-14
K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)Arrow International, LLC (A subsidiary of Teleflex, Inc.)2024-12-20
K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous CatheterSpectrum Vascular2024-11-27
K240359PowerGlide Pro™ Midline CatheterBecton, Dickinson and Company (Bard Access Systems, Inc.)2024-07-29
K241845Introcan Safety® 2 IV CatheterB.Braun Medical, Inc.2024-07-26
K233106AccuCath Ace™ Intravascular CatheterBard Access Systems, Inc. (C.R. Bard, Inc.)2024-04-19
K232234Nouvo Safety SetPoly Medicure Limited2024-03-15
K233529BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorBecton Dickinson Infusion Therapy Systems, Inc.2023-12-01
K231239Nexiva™ Closed IV Catheter System with NearPort™ IV AccessBecton Dickinson Infusion Therapy Systems, Inc.2023-09-22
K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited2023-09-21
K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety CatheterMedsource International, LLC2023-09-15
K231626OSPREY Closed IV Catheter System (OspreyV2)Skydance Vascular, Inc.2023-08-31
K221827Mais Central Venous CatheterSaudi Mais Co. For Medical Products2023-06-23
K230616Polyguard and Polyshield Safety IV CathetersPoly Medicure Limited2023-05-05
K223018OSPREY PERIPHERAL IV Catheter SystemSkydance Vascular, Inc.2023-04-14
K223648Cook® Spectrum® 2 MRC Central Venous CatheterCook Advanced Technologies2023-02-03
K220772HydroMID 4F Single Lumen Midline CatheterAccess Vascular, Inc.2022-12-07

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