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FDA 510(k)

Vial Adapter

K-Number: K260301 · 2026-06-05

ApplicantHangzhou Qiantang Longyue Biotechnology Co., Ltd.
Decision Date2026-06-05
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vial Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K260301. 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 Vial Adapter?

Vial Adapter is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. The 510(k) number is K260301.

When did Vial Adapter receive FDA 510(k) clearance?

Vial Adapter received FDA 510(k) clearance on 2026-06-05, under 510(k) number K260301.

Who is the listed applicant for Vial Adapter?

The FDA 510(k) record lists Hangzhou Qiantang Longyue Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial Adapter?

The FDA product code for Vial Adapter is LHI.

Other records listing Hangzhou Qiantang Longyue Biotechnology Co., 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.

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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.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 PharmaceuticalsK240761Arisure® Closed Male Luer with Spike Adapter (YM060)Yukon Medical, LLC

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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