Performer Introducer
K-Number: K173068 · 2017-11-17
ApplicantCook Incorporated
Decision Date2017-11-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Performer Introducer is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-11-17 under approval number K173068. 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 Performer Introducer?
Performer Introducer is a medical device that received FDA 510(k) clearance on 2017-11-17. It is manufactured by Cook Incorporated. The 510(k) number is K173068.
When was Performer Introducer approved by the FDA?
Performer Introducer received FDA 510(k) clearance on 2017-11-17, under approval number K173068.
What company makes Performer Introducer?
Performer Introducer is manufactured by Cook Incorporated.
What is the FDA product code for Performer Introducer?
The FDA product code for Performer Introducer 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.