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Concentric Guide Catheter, Models 90018, 90020

by Concentric Medical, Inc.

510(k) K003085

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 NumberK003085 Date7 Mar 2001ClearedStatusActive

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  • Withdrawn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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Concentric Guide Catheter, Models 90018 and 90020, is a percutaneous catheter designed to be introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire. It functions as a guide catheter to provide access and support during vascular procedures.

This device is manufactured by Concentric Medical, Inc. and is classified as Class II under product code DQY. It is supplied as a single-use device and must be stored in a dry environment. The device is intended for use in clinical settings where percutaneous vascular access is required.

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Questions

AI-generated answers, 27 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 Concentric Guide Catheter used for?

    It is a percutaneous guide catheter used to provide access and support during vascular procedures. It is introduced into a vein or artery through the skin using a dilator, sheath, or guide wire.

  • How is the Concentric Guide Catheter supplied?

    It is supplied as a single-use device. Each unit is intended for one patient use only and should not be reprocessed or reused.

  • What models are available for this device?

    The Concentric Guide Catheter is available in two models: 90018 and 90020. These models are designed for percutaneous vascular access and differ in specifications suitable for clinical needs.

  • How should the Concentric Guide Catheter be stored?

    The device must be stored in a dry environment. Proper storage conditions help maintain sterility and functionality prior to clinical use.

  • Is the Concentric Guide Catheter sterile?

    While the device data confirms it is single-use and supplied for sterile clinical environments, the exact sterility method (e.g., gamma irradiation or ethylene oxide) is not specified in the provided information.