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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 the device name listed in this FDA 510(k) record. The listed applicant is Simplivia Healthcare , Ltd.. It received FDA 510(k) clearance on 2020-05-07 under 510(k) 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. The listed applicant is Simplivia Healthcare , Ltd.. The 510(k) number is K192866.

When did Chemfort CSTD receive FDA 510(k) clearance?

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

Who is the listed applicant for Chemfort CSTD?

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

What is the FDA product code for Chemfort CSTD?

The FDA product code for Chemfort CSTD is ONB.

Other records listing Simplivia Healthcare , 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.

K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorK251411Chemfort Female Luer Lock AdaptorK231286Chemfort® Catheter AdaptorK210707OnGuard2 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

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.

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