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FDA 510(k)

Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor

K-Number: K180574 · 2018-08-17

ApplicantJ & J Solutions, Inc. D/B/A/ Corvida Medical
Decision Date2018-08-17
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is J & J Solutions, Inc. D/B/A/ Corvida Medical. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K180574. 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 Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor?

Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is J & J Solutions, Inc. D/B/A/ Corvida Medical. The 510(k) number is K180574.

When did Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor receive FDA 510(k) clearance?

Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor received FDA 510(k) clearance on 2018-08-17, under 510(k) number K180574.

Who is the listed applicant for Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor?

The FDA 510(k) record lists J & J Solutions, Inc. D/B/A/ Corvida Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor?

The FDA product code for Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor is ONB.

Related Clinical Trials

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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