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Performer Introducer

by Cook Incorporated 2 variants

510(k) K173068

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173068 Date17 Nov 2017ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DYB
Device class
Class II
Regulation
21 CFR Part 870.1340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Performer Introducer is a medical device designed to provide vascular access for the introduction of therapeutic or diagnostic instruments. It functions as a guiding sheath to facilitate the delivery of balloons, catheters, and other interventional devices into the vasculature.

This device is intended to provide stability during procedures and is suitable for use in challenging anatomies. It is supplied by Cook Incorporated and has received FDA 510(k) clearance under K173068.

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