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FDA 510(k)

Vial Adapter Ø13mm

K-Number: K220856 · 2022-06-21

ApplicantAvenir Performance Européenne Medical (Apem)
Decision Date2022-06-21
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vial Adapter Ø13mm is the device name listed in this FDA 510(k) record. The listed applicant is Avenir Performance Européenne Medical (Apem). It received FDA 510(k) clearance on 2022-06-21 under 510(k) number K220856. 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 Ø13mm?

Vial Adapter Ø13mm is a medical device that received FDA 510(k) clearance on 2022-06-21. The listed applicant is Avenir Performance Européenne Medical (Apem). The 510(k) number is K220856.

When did Vial Adapter Ø13mm receive FDA 510(k) clearance?

Vial Adapter Ø13mm received FDA 510(k) clearance on 2022-06-21, under 510(k) number K220856.

Who is the listed applicant for Vial Adapter Ø13mm?

The FDA 510(k) record lists Avenir Performance Européenne Medical (Apem) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial Adapter Ø13mm?

The FDA product code for Vial Adapter Ø13mm is LHI.

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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