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FDA 510(k)

PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE

K-Number: K043490 · 2005-02-18

ApplicantVidacare Corporation
Decision Date2005-02-18
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Vidacare Corporation. It received FDA 510(k) clearance on 2005-02-18 under 510(k) number K043490. 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 PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE?

PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE is a medical device that received FDA 510(k) clearance on 2005-02-18. The listed applicant is Vidacare Corporation. The 510(k) number is K043490.

When did PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE receive FDA 510(k) clearance?

PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE received FDA 510(k) clearance on 2005-02-18, under 510(k) number K043490.

Who is the listed applicant for PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE?

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 PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE?

The FDA product code for PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE is FMI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Vidacare Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120661THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACREK113872THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACAREK101026POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IOK091140EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IOK081713VERTEBRAL ACCESS SYSTEM BY VIDACAREK072045ONCONTROL BONE MARROW BIOPSY SYSTEM

View all 18 devices →

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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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