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FDA 510(k)

BD PhaSeal Optima Closed System Transfer Device

K-Number: K181221 · 2018-11-30

Decision Date2018-11-30
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD PhaSeal Optima Closed System Transfer Device is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K181221. 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 Transfer Device?

BD PhaSeal Optima Closed System Transfer Device is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K181221.

When did BD PhaSeal Optima Closed System Transfer Device receive FDA 510(k) clearance?

BD PhaSeal Optima Closed System Transfer Device received FDA 510(k) clearance on 2018-11-30, under 510(k) number K181221.

Who is the listed applicant for BD PhaSeal Optima Closed System Transfer Device?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Becton, Dickinson and Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: ONB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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