5.0 Fr Arndt Endobronchial Blocker Set
K-Number: K160542 · 2016-08-02
ApplicantCook Incorporated
Decision Date2016-08-02
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
5.0 Fr Arndt Endobronchial Blocker Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-08-02 under approval number K160542. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 5.0 Fr Arndt Endobronchial Blocker Set?
5.0 Fr Arndt Endobronchial Blocker Set is a medical device that received FDA 510(k) clearance on 2016-08-02. It is manufactured by Cook Incorporated. The 510(k) number is K160542.
When was 5.0 Fr Arndt Endobronchial Blocker Set approved by the FDA?
5.0 Fr Arndt Endobronchial Blocker Set received FDA 510(k) clearance on 2016-08-02, under approval number K160542.
What company makes 5.0 Fr Arndt Endobronchial Blocker Set?
5.0 Fr Arndt Endobronchial Blocker Set is manufactured by Cook Incorporated.
What is the FDA product code for 5.0 Fr Arndt Endobronchial Blocker Set?
The FDA product code for 5.0 Fr Arndt Endobronchial Blocker Set is CBI.
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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.