Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OnGuard2 Chemfort Closed Administration (CADM)

K-Number: K210707 · 2021-09-23

ApplicantSimplivia Healthcare , Ltd.
Decision Date2021-09-23
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OnGuard2 Chemfort Closed Administration (CADM) is a medical device manufactured by Simplivia Healthcare , Ltd.. It received FDA 510(k) clearance on 2021-09-23 under approval number K210707. 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 OnGuard2 Chemfort Closed Administration (CADM)?

OnGuard2 Chemfort Closed Administration (CADM) is a medical device that received FDA 510(k) clearance on 2021-09-23. It is manufactured by Simplivia Healthcare , Ltd.. The 510(k) number is K210707.

When was OnGuard2 Chemfort Closed Administration (CADM) approved by the FDA?

OnGuard2 Chemfort Closed Administration (CADM) received FDA 510(k) clearance on 2021-09-23, under approval number K210707.

What company makes OnGuard2 Chemfort Closed Administration (CADM)?

OnGuard2 Chemfort Closed Administration (CADM) is manufactured by Simplivia Healthcare , Ltd..

What is the FDA product code for OnGuard2 Chemfort Closed Administration (CADM)?

The FDA product code for OnGuard2 Chemfort Closed Administration (CADM) is ONB.

Related Clinical Trials

NCT06832163 Close Loop Smart Weaning for INO With PPHN RECRUITING NCT05454891 Extended Bolus for Meals in a Closed-loop System COMPLETED NCT06293638 Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor RECRUITING NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Simplivia Healthcare , Ltd.

K192866Chemfort CSTD 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.

↑