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FDA 510(k)

Qitexio

K-Number: K203738 · 2022-03-14

ApplicantMedex
Decision Date2022-03-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Qitexio is the device name listed in this FDA 510(k) record. The listed applicant is Medex. It received FDA 510(k) clearance on 2022-03-14 under 510(k) number K203738. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Qitexio?

Qitexio is a medical device that received FDA 510(k) clearance on 2022-03-14. The listed applicant is Medex. The 510(k) number is K203738.

When did Qitexio receive FDA 510(k) clearance?

Qitexio received FDA 510(k) clearance on 2022-03-14, under 510(k) number K203738.

Who is the listed applicant for Qitexio?

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

What is the FDA product code for Qitexio?

The FDA product code for Qitexio is FMF.

Other records listing Medex 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.

K242255Qitexio® 4-Way Stopcock (QIT014)

Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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.

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