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FDA 510(k)

Diana ChemoClave Transfer Set

K-Number: K190157 · 2019-10-23

ApplicantIcu Medical
Decision Date2019-10-23
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Diana ChemoClave Transfer Set is a medical device manufactured by Icu Medical. It received FDA 510(k) clearance on 2019-10-23 under approval number K190157. 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 Diana ChemoClave Transfer Set?

Diana ChemoClave Transfer Set is a medical device that received FDA 510(k) clearance on 2019-10-23. It is manufactured by Icu Medical. The 510(k) number is K190157.

When was Diana ChemoClave Transfer Set approved by the FDA?

Diana ChemoClave Transfer Set received FDA 510(k) clearance on 2019-10-23, under approval number K190157.

What company makes Diana ChemoClave Transfer Set?

Diana ChemoClave Transfer Set is manufactured by Icu Medical.

What is the FDA product code for Diana ChemoClave Transfer Set?

The FDA product code for Diana ChemoClave Transfer Set is ONB.

Other Devices by Icu Medical

K171346Sapphire Sets K192154Rio Vial-to-Bag Drug Reconstitution Device K190918SwabTip Male Disinfectant Cap K232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMS

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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