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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 a medical device manufactured by Simplivia Healthcare , Ltd.. It received FDA 510(k) clearance on 2023-08-02 under approval 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. It is manufactured by Simplivia Healthcare , Ltd.. The 510(k) number is K231286.

When was Chemfort® Catheter Adaptor approved by the FDA?

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

What company makes Chemfort® Catheter Adaptor?

Chemfort® Catheter Adaptor is manufactured by Simplivia Healthcare , Ltd..

What is the FDA product code for Chemfort® Catheter Adaptor?

The FDA product code for Chemfort® Catheter Adaptor is ONB.

Related Clinical Trials

NCT04498598 Structural Modification In Supraglottic Airway Device RECRUITING

Other Devices by Simplivia Healthcare , Ltd.

K192866Chemfort CSTD 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 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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