Peel-Away Introducer Set
K-Number: K173685 · 2017-12-20
ApplicantCook Incorporated
Decision Date2017-12-20
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Peel-Away Introducer Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-12-20 under approval number K173685. 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 Peel-Away Introducer Set?
Peel-Away Introducer Set is a medical device that received FDA 510(k) clearance on 2017-12-20. It is manufactured by Cook Incorporated. The 510(k) number is K173685.
When was Peel-Away Introducer Set approved by the FDA?
Peel-Away Introducer Set received FDA 510(k) clearance on 2017-12-20, under approval number K173685.
What company makes Peel-Away Introducer Set?
Peel-Away Introducer Set is manufactured by Cook Incorporated.
What is the FDA product code for Peel-Away Introducer Set?
The FDA product code for Peel-Away 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.