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)

Chemfort® Catheter Adaptor

K-Number: K231286 · 2023-08-02

ApplicantSimplivia Healthcare , Ltd.
Decision Date2023-08-02
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Chemfort® Catheter Adaptor 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 2023-08-02 under 510(k) number K231286. 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® Catheter Adaptor?

Chemfort® Catheter Adaptor is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Simplivia Healthcare , Ltd.. The 510(k) number is K231286.

When did Chemfort® Catheter Adaptor receive FDA 510(k) clearance?

Chemfort® Catheter Adaptor received FDA 510(k) clearance on 2023-08-02, under 510(k) number K231286.

Who is the listed applicant for Chemfort® Catheter Adaptor?

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® Catheter Adaptor?

The FDA product code for Chemfort® Catheter Adaptor 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 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 setK192866Chemfort 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑