FDA 510(k)

POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO

K-Number: K101026 · 2010-07-27

Decision Date2010-07-27

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO is the device name listed in this FDA 510(k) record. The listed applicant is Vidacare Corporation. It received FDA 510(k) clearance on 2010-07-27 under 510(k) number K101026. 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 POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO?

POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO is a medical device that received FDA 510(k) clearance on 2010-07-27. The listed applicant is Vidacare Corporation. The 510(k) number is K101026.

When did POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO receive FDA 510(k) clearance?

POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO received FDA 510(k) clearance on 2010-07-27, under 510(k) number K101026.

Who is the listed applicant for POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO?

The FDA 510(k) record lists Vidacare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO?

The FDA product code for POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO is FMI.

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Other records listing Vidacare Corporation as applicant

K120661THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE K113872THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE K091140EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO K081713VERTEBRAL ACCESS SYSTEM BY VIDACARE K072045ONCONTROL BONE MARROW BIOPSY SYSTEM K070759POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM

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Official Source

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