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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-05-29 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K182403.

When did Peel-Away Introducer receive FDA 510(k) clearance?

Peel-Away Introducer received FDA 510(k) clearance on 2019-05-29, under 510(k) number K182403.

Who is the listed applicant for Peel-Away Introducer?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

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.

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