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FDA 510(k)

Guarded Luer Connector

K-Number: K173577 · 2018-06-07

ApplicantInternational Medical Industries, Inc.
Decision Date2018-06-07
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Guarded Luer Connector is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Industries, Inc.. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K173577. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Guarded Luer Connector?

Guarded Luer Connector is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is International Medical Industries, Inc.. The 510(k) number is K173577.

When did Guarded Luer Connector receive FDA 510(k) clearance?

Guarded Luer Connector received FDA 510(k) clearance on 2018-06-07, under 510(k) number K173577.

Who is the listed applicant for Guarded Luer Connector?

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

What is the FDA product code for Guarded Luer Connector?

The FDA product code for Guarded Luer Connector is LHI.

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Related Devices (Code: LHI)

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K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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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