Modified Concentric Microcatheter

• • Ongoing Z-1904-2024 FDA Class II ·initiated 23 Apr 2024

  Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

• • Ongoing Z-1084-2024 FDA Class II ·initiated 6 Dec 2023

  The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

510(k) Number

K131437 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

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

• 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

• 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)

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