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FDA 510(k)

MixJect® Transfer Device

K-Number: K230464 · 2023-05-22

ApplicantWest Pharma. Services IL, Ltd.
Decision Date2023-05-22
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MixJect® Transfer Device is a medical device manufactured by West Pharma. Services IL, Ltd.. It received FDA 510(k) clearance on 2023-05-22 under approval number K230464. 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 MixJect® Transfer Device?

MixJect® Transfer Device is a medical device that received FDA 510(k) clearance on 2023-05-22. It is manufactured by West Pharma. Services IL, Ltd.. The 510(k) number is K230464.

When was MixJect® Transfer Device approved by the FDA?

MixJect® Transfer Device received FDA 510(k) clearance on 2023-05-22, under approval number K230464.

What company makes MixJect® Transfer Device?

MixJect® Transfer Device is manufactured by West Pharma. Services IL, Ltd..

What is the FDA product code for MixJect® Transfer Device?

The FDA product code for MixJect® Transfer Device is LHI.

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Other Devices by West Pharma. Services IL, Ltd.

K213513Vented Vial Adapter 20mm K232875Vial Adapter 20mm K230988Vial2Bag Advanced® 13mm Admixture Device K231071Mix2Vial® Transfer Device

Related Devices (Code: LHI)

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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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