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FDA 510(k)

Equashield Closed System drug Transfer Device (CSTD)

K-Number: K170706 · 2017-07-03

ApplicantEquashield Medical , Ltd.
Decision Date2017-07-03
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Equashield Closed System drug Transfer Device (CSTD) is a medical device manufactured by Equashield Medical , Ltd.. It received FDA 510(k) clearance on 2017-07-03 under approval number K170706. 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 drug Transfer Device (CSTD)?

Equashield Closed System drug Transfer Device (CSTD) is a medical device that received FDA 510(k) clearance on 2017-07-03. It is manufactured by Equashield Medical , Ltd.. The 510(k) number is K170706.

When was Equashield Closed System drug Transfer Device (CSTD) approved by the FDA?

Equashield Closed System drug Transfer Device (CSTD) received FDA 510(k) clearance on 2017-07-03, under approval number K170706.

What company makes Equashield Closed System drug Transfer Device (CSTD)?

Equashield Closed System drug Transfer Device (CSTD) is manufactured by Equashield Medical , Ltd..

What is the FDA product code for Equashield Closed System drug Transfer Device (CSTD)?

The FDA product code for Equashield Closed System drug Transfer Device (CSTD) is ONB.

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Other Devices by Equashield Medical , Ltd.

K221513Equashield Closed System Transfer Device

Related Devices (Code: ONB)

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 K170110Diana Medication Transfer SetIcu Medical, Inc.

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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