Peel-Away Introducer
K-Number: K182403 · 2019-05-29
ApplicantCook Incorporated
Decision Date2019-05-29
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Peel-Away Introducer is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-05-29 under approval number K182403. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Peel-Away Introducer?
Peel-Away Introducer is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by Cook Incorporated. The 510(k) number is K182403.
When was Peel-Away Introducer approved by the FDA?
Peel-Away Introducer received FDA 510(k) clearance on 2019-05-29, under approval number K182403.
What company makes Peel-Away Introducer?
Peel-Away Introducer is manufactured by Cook Incorporated.
What is the FDA product code for Peel-Away Introducer?
The FDA product code for Peel-Away Introducer is FED.
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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.