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FDA 510(k)

MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL

K-Number: K083765 · 2008-12-30

ApplicantMedegen Medical Manufacturing Services
Decision Date2008-12-30
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL is the device name listed in this FDA 510(k) record. The listed applicant is Medegen Medical Manufacturing Services. It received FDA 510(k) clearance on 2008-12-30 under 510(k) number K083765. 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 MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL?

MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL is a medical device that received FDA 510(k) clearance on 2008-12-30. The listed applicant is Medegen Medical Manufacturing Services. The 510(k) number is K083765.

When did MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL receive FDA 510(k) clearance?

MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL received FDA 510(k) clearance on 2008-12-30, under 510(k) number K083765.

Who is the listed applicant for MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL?

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

What is the FDA product code for MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL?

The FDA product code for MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL is FPA.

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Other records listing Medegen Medical Manufacturing Services 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.

K052330TRU-SWAB STOCOCKK051930DRUG ACCESS SPIKEK051499INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET

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

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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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