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FDA 510(k)

Vial2Bag Advanced® 13mm Admixture Device

K-Number: K230988 · 2023-12-01

ApplicantWest Pharma. Services IL, Ltd.
Decision Date2023-12-01
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vial2Bag Advanced® 13mm Admixture Device is the device name listed in this FDA 510(k) record. The listed applicant is West Pharma. Services IL, Ltd.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K230988. 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 Vial2Bag Advanced® 13mm Admixture Device?

Vial2Bag Advanced® 13mm Admixture Device is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is West Pharma. Services IL, Ltd.. The 510(k) number is K230988.

When did Vial2Bag Advanced® 13mm Admixture Device receive FDA 510(k) clearance?

Vial2Bag Advanced® 13mm Admixture Device received FDA 510(k) clearance on 2023-12-01, under 510(k) number K230988.

Who is the listed applicant for Vial2Bag Advanced® 13mm Admixture Device?

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

What is the FDA product code for Vial2Bag Advanced® 13mm Admixture Device?

The FDA product code for Vial2Bag Advanced® 13mm Admixture Device is LHI.

Other records listing West Pharma. Services IL, 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.

K231071Mix2Vial® Transfer DeviceK232875Vial Adapter 20mmK230464MixJect® Transfer DeviceK213513Vented Vial Adapter 20mm

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

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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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