Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Yukon Medical, LLC. It received FDA 510(k) clearance on 2021-03-02 under 510(k) 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. The listed applicant is Yukon Medical, LLC. The 510(k) number is K201422.

When did Arisure Closed System Drug Transfer Device (CSTD) receive FDA 510(k) clearance?

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

Who is the listed applicant for Arisure Closed System Drug Transfer Device (CSTD)?

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

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.

Other records listing Yukon Medical, LLC 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.

K240761Arisure® Closed Male Luer with Spike Adapter (YM060)K243486SmartSiteTM Vented Vial Access DeviceK172884Arisure Closed Vial AdapterK172631Arisure Dry SpikeK171101Closed Male Luer

Related Devices (Code: ONB)

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.

K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte. , Ltd.K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and CompanyK251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare , Ltd.K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte. , Ltd.K243976ZeroClear™ Bag Access (423100)Epic Medical Pte. , Ltd.

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.

↑