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FDA 510(k)

TEXIUM SYRINGE

K-Number: K071108 · 2007-05-24

ApplicantCardinal Health, Alaris Products
Decision Date2007-05-24
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEXIUM SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Alaris Products. It received FDA 510(k) clearance on 2007-05-24 under 510(k) number K071108. 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 TEXIUM SYRINGE?

TEXIUM SYRINGE is a medical device that received FDA 510(k) clearance on 2007-05-24. The listed applicant is Cardinal Health, Alaris Products. The 510(k) number is K071108.

When did TEXIUM SYRINGE receive FDA 510(k) clearance?

TEXIUM SYRINGE received FDA 510(k) clearance on 2007-05-24, under 510(k) number K071108.

Who is the listed applicant for TEXIUM SYRINGE?

The FDA 510(k) record lists Cardinal Health, Alaris Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEXIUM SYRINGE?

The FDA product code for TEXIUM SYRINGE is FMF.

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Other records listing Cardinal Health, Alaris Products 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.

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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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.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.

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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