Skip to content

Modified Concentric Retriever, Model 90037

by Concentric Medical, Inc.

510(k) K030476

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 · Special NumberK030476 Date11 Mar 2003ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0086-04 FDA Unclassified (pre-2012) initiated 24 Sep 2003
    • Terminated Z-0085-04 FDA Unclassified (pre-2012) initiated 24 Sep 2003

    The device has the potential for tip breakage during use.

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  • Withdrawn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 Modified Concentric Retriever, Model 90037 is a specialized tool designed to retrieve thrombi or foreign objects from the venous system. It consists of a Nitinol tapered wire with a helical distal tip and a platinum coil, which allows for effective engagement and retrieval of obstructions within neuro, peripheral, and coronary vascular systems.

This device is operated by clinicians during interventional radiological procedures, with fluoroscopic visualization enabled by the radiopaque distal coil. It is authorized under FDA 510(k) clearance K030476.

Other devices from Concentric Medical, Inc.

See all devices from Concentric Medical, Inc. →

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 primary function of the Modified Concentric Retriever, Model 90037?

    This device is a specialized tool engineered to retrieve thrombi or foreign objects from the venous system. It is designed for use within neuro, peripheral, and coronary vascular systems to address obstructions.

  • How is the device visualized during a procedure?

    The retriever features a radiopaque platinum coil at the distal tip. This allows clinicians to maintain fluoroscopic visualization of the device while navigating and performing interventional radiological procedures.

  • What materials are used in the construction of this retriever?

    The device is constructed from a Nitinol tapered wire, which provides the necessary mechanical properties for vascular navigation, and includes a platinum coil at the distal end to facilitate radiopacity.

  • What is the regulatory status of this device?

    The Modified Concentric Retriever, Model 90037, is authorized under FDA 510(k) clearance K030476, which indicates that the device has been found substantially equivalent to legally marketed predicate devices.