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FDA 510(k)

EZ-IO Intraosseous Vascular Access System

K-Number: K180395 · 2018-11-09

ApplicantArrow International, Inc. (Subsidiary of Teleflex, Inc.)
Decision Date2018-11-09
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EZ-IO Intraosseous Vascular Access System is a medical device manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2018-11-09 under approval number K180395. 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 2018-11-09. It is manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K180395.

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

EZ-IO Intraosseous Vascular Access System received FDA 510(k) clearance on 2018-11-09, under approval number K180395.

What company makes EZ-IO Intraosseous Vascular Access System?

EZ-IO Intraosseous Vascular Access System is manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.).

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 Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology K160018Arrow Quickflash Arterial Catheterization Device K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC K163513Arrow Endurance Extended Dwell Peripheral Catheter System

Related Devices (Code: FMI)

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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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