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FDA 510(k)

EZ-IO Intraosseous Vascular Access System

K-Number: K231924 · 2023-07-25

ApplicantTeleflex Medical
Decision Date2023-07-25
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZ-IO Intraosseous Vascular Access System is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2023-07-25 under approval number K231924. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-IO Intraosseous Vascular Access System?

EZ-IO Intraosseous Vascular Access System is a medical device that received FDA 510(k) clearance on 2023-07-25. It is manufactured by Teleflex Medical. The 510(k) number is K231924.

When was EZ-IO Intraosseous Vascular Access System approved by the FDA?

EZ-IO Intraosseous Vascular Access System received FDA 510(k) clearance on 2023-07-25, under approval number K231924.

What company makes EZ-IO Intraosseous Vascular Access System?

EZ-IO Intraosseous Vascular Access System is manufactured by Teleflex Medical.

What is the FDA product code for EZ-IO Intraosseous Vascular Access System?

The FDA product code for EZ-IO Intraosseous Vascular Access System is FMI.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT06099015 Cera™ Vascular Plug System Post-Market Clinical Follow-Up RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT06904651 VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Teleflex Medical

K161758Weck Auto Endo10 Automatic Endoscopic Clip Applier K153470MADgic Laryngo-Tracheal Mucosal Atomization Device K180253Sheridan Endobronchial Tubes K173321StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device K173596Rusch Intermittent Urethral Catheters

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Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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