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Merci Retriever, Models 90065, 90066

by Concentric Medical, Inc.

510(k) K033736

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 NumberK033736 Date11 Aug 2004ClearedStatusActive

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  • Withdrawn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
NRY
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 Merci Retriever is a thrombus retrieval device intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. It is designed for use in patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA). The device is classified as a Catheter, Thrombus Retriever in the cardiovascular medical specialty.

The Merci Retriever is supplied as a single-use device and requires appropriate storage conditions. It is available in multiple models including 90065 and 90066, with various sizes and configurations. The device received FDA 510(k) clearance with K033736 on August 11, 2004, and is regulated under product code NRY with regulation number 870.1250.

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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 Merci Retriever used for?

    The Merci Retriever is a thrombus retrieval device designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA).

  • How is the Merci Retriever supplied and is it single-use?

    The Merci Retriever is supplied as a single-use device and requires appropriate storage conditions. It is available in multiple models including 90065 and 90066, with various sizes and configurations to accommodate different clinical needs.

  • What regulatory status does the Merci Retriever have?

    The Merci Retriever received FDA 510(k) clearance with K033736 on August 11, 2004, and is regulated under product code NRY with regulation number 870.1250. It is classified as a Class II device in the cardiovascular medical specialty.

  • What are the different models of the Merci Retriever available?

    The Merci Retriever is available in multiple models including 90065 and 90066, with various sizes and configurations. These different models are designed to accommodate different anatomical considerations and clinical requirements during thrombus retrieval procedures.