Modification to Merci Retriever

• • Terminated Z-2598-2014 FDA Class II ·initiated 25 Jun 2014

  Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.

510(k) Number

K082034 ↗

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

• Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm

  Class II

  FDA De Novo DEN150049 Active Cleared 2 Sep 2016 FDA 510(k)

See all devices from Concentric Medical, Inc. →