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FDA 510(k)

CYTOGUARD(TM) CLOSED LUER CONNECTOR

K-Number: K112636 · 2011-11-26

ApplicantB.Braun Medical, Inc.
Decision Date2011-11-26
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CYTOGUARD(TM) CLOSED LUER CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2011-11-26 under 510(k) number K112636. 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 CYTOGUARD(TM) CLOSED LUER CONNECTOR?

CYTOGUARD(TM) CLOSED LUER CONNECTOR is a medical device that received FDA 510(k) clearance on 2011-11-26. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K112636.

When did CYTOGUARD(TM) CLOSED LUER CONNECTOR receive FDA 510(k) clearance?

CYTOGUARD(TM) CLOSED LUER CONNECTOR received FDA 510(k) clearance on 2011-11-26, under 510(k) number K112636.

Who is the listed applicant for CYTOGUARD(TM) CLOSED LUER CONNECTOR?

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

What is the FDA product code for CYTOGUARD(TM) CLOSED LUER CONNECTOR?

The FDA product code for CYTOGUARD(TM) CLOSED LUER CONNECTOR is FPA.

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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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