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FDA 510(k)

Arisure Closed System Drug Transfer Device (CSTD)

K-Number: K201422 · 2021-03-02

ApplicantYukon Medical, LLC
Decision Date2021-03-02
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Arisure Closed System Drug Transfer Device (CSTD) is a medical device manufactured by Yukon Medical, LLC. It received FDA 510(k) clearance on 2021-03-02 under approval number K201422. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arisure Closed System Drug Transfer Device (CSTD)?

Arisure Closed System Drug Transfer Device (CSTD) is a medical device that received FDA 510(k) clearance on 2021-03-02. It is manufactured by Yukon Medical, LLC. The 510(k) number is K201422.

When was Arisure Closed System Drug Transfer Device (CSTD) approved by the FDA?

Arisure Closed System Drug Transfer Device (CSTD) received FDA 510(k) clearance on 2021-03-02, under approval number K201422.

What company makes Arisure Closed System Drug Transfer Device (CSTD)?

Arisure Closed System Drug Transfer Device (CSTD) is manufactured by Yukon Medical, LLC.

What is the FDA product code for Arisure Closed System Drug Transfer Device (CSTD)?

The FDA product code for Arisure Closed System Drug Transfer Device (CSTD) is ONB.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Yukon Medical, LLC

K243486SmartSiteTM Vented Vial Access Device K240761Arisure® Closed Male Luer with Spike Adapter (YM060)

Related Devices (Code: ONB)

K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical , Ltd. K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant K181221BD PhaSeal Optima Closed System Transfer DeviceBecton, Dickinson and Company K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc. K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial AdaptorJ & J Solutions, Inc. D/B/A/ Corvida Medical

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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