FDA 510(k)

POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM

K-Number: K051992 · 2005-10-20

Decision Date2005-10-20

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vidacare Corporation. It received FDA 510(k) clearance on 2005-10-20 under 510(k) number K051992. 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 INTRAOSSEOUS INFUSION SYSTEM?

POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-20. The listed applicant is Vidacare Corporation. The 510(k) number is K051992.

When did POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM receive FDA 510(k) clearance?

POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM received FDA 510(k) clearance on 2005-10-20, under 510(k) number K051992.

Who is the listed applicant for POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM?

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 INTRAOSSEOUS INFUSION SYSTEM?

The FDA product code for POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM 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 K101026POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO K091140EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO K081713VERTEBRAL ACCESS SYSTEM BY VIDACARE K072045ONCONTROL BONE MARROW BIOPSY 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.