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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 a medical device manufactured by Advcare Medical. It received FDA 510(k) clearance on 2022-08-19 under approval 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. It is manufactured by Advcare Medical. The 510(k) number is K212525.

When was Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices approved by the FDA?

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

What company makes Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices?

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices is manufactured by Advcare Medical.

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.

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Related PubMed Literature

PMID: 41298848 FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges. Npj mental health research (2025) PMID: 39993988 [Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

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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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