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FDA 510(k)

Equashield Closed System Transfer Device

K-Number: K221513 · 2023-02-17

ApplicantEquashield Medical , Ltd.
Decision Date2023-02-17
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Equashield Closed System Transfer Device is the device name listed in this FDA 510(k) record. The listed applicant is Equashield Medical , Ltd.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K221513. 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 Equashield Closed System Transfer Device?

Equashield Closed System Transfer Device is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Equashield Medical , Ltd.. The 510(k) number is K221513.

When did Equashield Closed System Transfer Device receive FDA 510(k) clearance?

Equashield Closed System Transfer Device received FDA 510(k) clearance on 2023-02-17, under 510(k) number K221513.

Who is the listed applicant for Equashield Closed System Transfer Device?

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

What is the FDA product code for Equashield Closed System Transfer Device?

The FDA product code for Equashield Closed System Transfer Device is ONB.

Other records listing Equashield Medical , Ltd. 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.

K170706Equashield Closed System drug Transfer Device (CSTD)

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

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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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