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FDA 510(k)

BD PhaSeal Optima Closed System Drug Transfer Device

K-Number: K201099 · 2020-08-12

ApplicantBecton, Dickinson and Company
Decision Date2020-08-12
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD PhaSeal Optima Closed System Drug Transfer Device is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2020-08-12 under approval number K201099. 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 BD PhaSeal Optima Closed System Drug Transfer Device?

BD PhaSeal Optima Closed System Drug Transfer Device is a medical device that received FDA 510(k) clearance on 2020-08-12. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K201099.

When was BD PhaSeal Optima Closed System Drug Transfer Device approved by the FDA?

BD PhaSeal Optima Closed System Drug Transfer Device received FDA 510(k) clearance on 2020-08-12, under approval number K201099.

What company makes BD PhaSeal Optima Closed System Drug Transfer Device?

BD PhaSeal Optima Closed System Drug Transfer Device is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD PhaSeal Optima Closed System Drug Transfer Device?

The FDA product code for BD PhaSeal Optima Closed System Drug Transfer Device is ONB.

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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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