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FDA 510(k)

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices

K-Number: K212525 · 2022-08-19

ApplicantAdvcare Medical
Decision Date2022-08-19
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices is the device name listed in this FDA 510(k) record. The listed applicant is Advcare Medical. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K212525. 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 Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices?

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Advcare Medical. The 510(k) number is K212525.

When did Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices receive FDA 510(k) clearance?

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices received FDA 510(k) clearance on 2022-08-19, under 510(k) number K212525.

Who is the listed applicant for Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices?

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

What is the FDA product code for Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices?

The FDA product code for Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices 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

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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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