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FDA 510(k)

EQUALSHIELD LUER LOCK CONNECTOR PAIR

K-Number: K091389 · 2009-10-22

ApplicantPlastmed, Ltd.
Decision Date2009-10-22
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EQUALSHIELD LUER LOCK CONNECTOR PAIR is the device name listed in this FDA 510(k) record. The listed applicant is Plastmed, Ltd.. It received FDA 510(k) clearance on 2009-10-22 under 510(k) number K091389. 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 EQUALSHIELD LUER LOCK CONNECTOR PAIR?

EQUALSHIELD LUER LOCK CONNECTOR PAIR is a medical device that received FDA 510(k) clearance on 2009-10-22. The listed applicant is Plastmed, Ltd.. The 510(k) number is K091389.

When did EQUALSHIELD LUER LOCK CONNECTOR PAIR receive FDA 510(k) clearance?

EQUALSHIELD LUER LOCK CONNECTOR PAIR received FDA 510(k) clearance on 2009-10-22, under 510(k) number K091389.

Who is the listed applicant for EQUALSHIELD LUER LOCK CONNECTOR PAIR?

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

What is the FDA product code for EQUALSHIELD LUER LOCK CONNECTOR PAIR?

The FDA product code for EQUALSHIELD LUER LOCK CONNECTOR PAIR is LHI.

Related Clinical Trials

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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Other records listing Plastmed, Ltd. 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.

K083152EQUASHIELD SYSTEM

Related Devices (Code: LHI)

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.

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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