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FDA 510(k)

NEXUS TKO-6, LUER-ACTIVATED DEVICE

K-Number: K113398 · 2012-04-18

ApplicantNexus Medical, LLC
Decision Date2012-04-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEXUS TKO-6, LUER-ACTIVATED DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Nexus Medical, LLC. It received FDA 510(k) clearance on 2012-04-18 under 510(k) number K113398. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXUS TKO-6, LUER-ACTIVATED DEVICE?

NEXUS TKO-6, LUER-ACTIVATED DEVICE is a medical device that received FDA 510(k) clearance on 2012-04-18. The listed applicant is Nexus Medical, LLC. The 510(k) number is K113398.

When did NEXUS TKO-6, LUER-ACTIVATED DEVICE receive FDA 510(k) clearance?

NEXUS TKO-6, LUER-ACTIVATED DEVICE received FDA 510(k) clearance on 2012-04-18, under 510(k) number K113398.

Who is the listed applicant for NEXUS TKO-6, LUER-ACTIVATED DEVICE?

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

What is the FDA product code for NEXUS TKO-6, LUER-ACTIVATED DEVICE?

The FDA product code for NEXUS TKO-6, LUER-ACTIVATED DEVICE is FPA.

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Other records listing Nexus Medical, LLC 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.

K130879NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUSK130416NEXUS TKO-6P LUER ACTIVATED DEVICEK092382NEXUS PRESSURE RATED EXTENSION SETSK092930NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCEDK092527NEXUS INJECTION SITE, MODEL NIS-8K081123NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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