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 a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-07-27 under approval 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. It is manufactured by Cook Incorporated. The 510(k) number is K163031.
When was Bunegin-Albin Air Aspiration Set approved by the FDA?
Bunegin-Albin Air Aspiration Set received FDA 510(k) clearance on 2017-07-27, under approval number K163031.
What company makes Bunegin-Albin Air Aspiration Set?
Bunegin-Albin Air Aspiration Set is manufactured by Cook Incorporated.
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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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.