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Check-Flo Performer Introducer Micropuncture Radial Artery Access Set

by Cook Incorporated

510(k) K171609

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171609 Date4 Jun 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 28 Sep 2026

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

The Check-Flo Performer Introducer Micropuncture Radial Artery Access Set is a sterile, single-use catheter introducer system used in clinical settings for radial artery access. The set comprises an introducer sheath, dilator, 21-gauge needle, and wire guide; some configurations include a luer locking syringe. It is designed to introduce diagnostic and interventional devices in radial artery access procedures.

The device is supplied sterile and intended for single-use only. It is used in clinical settings to facilitate percutaneous introduction of therapeutic or diagnostic devices into the vasculature via radial artery access. Authorization is based on FDA 510(k) clearance under product code DYB, with substantial equivalence established via traditional review.

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Questions

AI-generated answers, 28 Sep 2026

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

  • What is the Check-Flo Performer Introducer Micropuncture Radial Artery Access Set used for?

    It is used to facilitate percutaneous introduction of diagnostic or interventional devices into the vasculature via radial artery access in clinical settings, enabling procedures such as angiography or stent placement through a minimally invasive approach.

  • Is the Check-Flo Performer Introducer Micropuncture Radial Artery Access Set sterile and single-use?

    Yes, the device is supplied sterile and intended for single-use only, as stated in the device description, to prevent cross-contamination and ensure patient safety during vascular access procedures.

  • What components are included in the Check-Flo Performer Introducer Micropuncture Radial Artery Access Set?

    The set includes an introducer sheath, dilator, 21-gauge needle, and wire guide; some configurations may also include a luer locking syringe, depending on the specific model or reference number ordered.

  • How is the Check-Flo Performer Introducer Micropuncture Radial Artery Access Set authorized for use?

    The device received FDA 510(k) clearance under product code DYB, with substantial equivalence established through a traditional review process, as indicated in the authorization and decision details provided.