Modified Hd Guide Catheter

• • Ongoing Z-1908-2024 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-1740-2024 FDA Class II ·initiated 3 Apr 2024

  Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.

• • Terminated Z-0116-2016 FDA Class II ·initiated 19 Aug 2015

  One Distal Access Catheter intended for distribution in Korea, was found at a US location.

510(k) Number

K133177 ↗

FDA Product Code

DQY

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. →