Modified Merci Retriever, Model 90092

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

510(k) Number

K061059 ↗

FDA Product Code

NRY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modified Trevo Provue Retriever Open recall

  Class II

  FDA 510(k) K133464 Active Cleared 17 Jan 2014

• Modified Concentric Microcatheter Open recall

  Class II

  FDA 510(k) K131437 Active Cleared 11 Oct 2013

• Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113

  Class II

  FDA 510(k) K090085 Active Cleared 12 Feb 2009

• Modified Hd Guide Catheter

  Class II

  FDA 510(k) K110483 Active Cleared 4 Apr 2011

• Modified Concentric Microcatheter, Model 90047

  Class II

  FDA 510(k) K091961 Active Cleared 30 Jul 2009

• Modification to Merci Retriever

  Class II

  FDA 510(k) K082034 Active Cleared 15 Aug 2008

See all devices from Concentric Medical, Inc. →

• What is the Modified Merci Retriever, Model 90092 used for?

  The Modified Merci Retriever, Model 90092 is a catheter-based thrombus retriever device designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. It is used in neurovascular procedures under physician direction to mechanically extract blood clots from cerebral arteries.

• How is the Modified Merci Retriever, Model 90092 supplied and is it reusable?

  The device is supplied sterile and intended for single-use only. It must not be reused, reprocessed, or resterilized, as doing so could compromise its structural integrity, introduce contamination risks, and jeopardize patient safety during neurovascular thrombectomy procedures.

• What regulatory pathway was used for the Modified Merci Retriever, Model 90092?

  The Modified Merci Retriever, Model 90092 received FDA 510(k) clearance (K061059) as substantially equivalent to the predicate Merci® Retriever X6. This means it was evaluated for safety and effectiveness based on its technological characteristics and performance compared to a legally marketed device.