Edwards eSheath Introducer Set
K-Number: K162184 · 2016-09-02
ApplicantEdward Lifesciences
Decision Date2016-09-02
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Edwards eSheath Introducer Set is a medical device manufactured by Edward Lifesciences. It received FDA 510(k) clearance on 2016-09-02 under approval number K162184. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Edwards eSheath Introducer Set?
Edwards eSheath Introducer Set is a medical device that received FDA 510(k) clearance on 2016-09-02. It is manufactured by Edward Lifesciences. The 510(k) number is K162184.
When was Edwards eSheath Introducer Set approved by the FDA?
Edwards eSheath Introducer Set received FDA 510(k) clearance on 2016-09-02, under approval number K162184.
What company makes Edwards eSheath Introducer Set?
Edwards eSheath Introducer Set is manufactured by Edward Lifesciences.
What is the FDA product code for Edwards eSheath Introducer Set?
The FDA product code for Edwards eSheath Introducer Set is DYB.
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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.