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FDA 510(k)

TEVADAPTOR Closed Drug Reconstitution and Transfer System

K-Number: K170680 · 2017-05-16

ApplicantTeva Medical Ltd., Migada Plant
Decision Date2017-05-16
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEVADAPTOR Closed Drug Reconstitution and Transfer System is a medical device manufactured by Teva Medical Ltd., Migada Plant. It received FDA 510(k) clearance on 2017-05-16 under approval number K170680. 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 TEVADAPTOR Closed Drug Reconstitution and Transfer System?

TEVADAPTOR Closed Drug Reconstitution and Transfer System is a medical device that received FDA 510(k) clearance on 2017-05-16. It is manufactured by Teva Medical Ltd., Migada Plant. The 510(k) number is K170680.

When was TEVADAPTOR Closed Drug Reconstitution and Transfer System approved by the FDA?

TEVADAPTOR Closed Drug Reconstitution and Transfer System received FDA 510(k) clearance on 2017-05-16, under approval number K170680.

What company makes TEVADAPTOR Closed Drug Reconstitution and Transfer System?

TEVADAPTOR Closed Drug Reconstitution and Transfer System is manufactured by Teva Medical Ltd., Migada Plant.

What is the FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

The FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System is ONB.

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Other Devices by Teva Medical Ltd., Migada Plant

K180489TEVADAPTOR Closed Drug Reconstitution and Transfer System

Related Devices (Code: ONB)

K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical , Ltd. 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 K170110Diana Medication Transfer SetIcu Medical, Inc.

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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