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FDA 510(k)

Bunegin-Albin Air Aspiration Set

K-Number: K163031 · 2017-07-27

ApplicantCook Incorporated
Decision Date2017-07-27
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bunegin-Albin Air Aspiration Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-07-27 under 510(k) number K163031. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bunegin-Albin Air Aspiration Set?

Bunegin-Albin Air Aspiration Set is a medical device that received FDA 510(k) clearance on 2017-07-27. The listed applicant is Cook Incorporated. The 510(k) number is K163031.

When did Bunegin-Albin Air Aspiration Set receive FDA 510(k) clearance?

Bunegin-Albin Air Aspiration Set received FDA 510(k) clearance on 2017-07-27, under 510(k) number K163031.

Who is the listed applicant for Bunegin-Albin Air Aspiration Set?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bunegin-Albin Air Aspiration Set?

The FDA product code for Bunegin-Albin Air Aspiration Set is DXE.

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Related Devices (Code: DXE)

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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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