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FDA 510(k)

Chemfort CSTD

K-Number: K192866 · 2020-05-07

ApplicantSimplivia Healthcare , Ltd.
Decision Date2020-05-07
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Chemfort CSTD is a medical device manufactured by Simplivia Healthcare , Ltd.. It received FDA 510(k) clearance on 2020-05-07 under approval number K192866. 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 Chemfort CSTD?

Chemfort CSTD is a medical device that received FDA 510(k) clearance on 2020-05-07. It is manufactured by Simplivia Healthcare , Ltd.. The 510(k) number is K192866.

When was Chemfort CSTD approved by the FDA?

Chemfort CSTD received FDA 510(k) clearance on 2020-05-07, under approval number K192866.

What company makes Chemfort CSTD?

Chemfort CSTD is manufactured by Simplivia Healthcare , Ltd..

What is the FDA product code for Chemfort CSTD?

The FDA product code for Chemfort CSTD is ONB.

Other Devices by Simplivia Healthcare , Ltd.

K210707OnGuard2 Chemfort Closed Administration (CADM) K201142TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set K231286Chemfort® Catheter Adaptor K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor K251411Chemfort Female Luer Lock Adaptor

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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