Trevo Trak 21 Microcatheter

• • Ongoing Z-0021-2025 FDA Class II ·initiated 30 Aug 2024

  Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.

• • Ongoing Z-1906-2024 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-1085-2024 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

K211594 ↗

FDA Product Code

QJP

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Wingspan

  Class III

  CE/MDR MDR 739951 Active Valid to May 2028

• AXS Catalyst 6

  Class III

  CE/MDR MDR 736172 Active Valid to Mar 2028

• Trenza

  Class III

  CE/MDR MDR 829526 Active Valid to Jun 2031

• AXS Catalyst 5

  Class III

  CE/MDR MDR 736172 Active Valid to Mar 2028

• AXS Catalyst 7

  Class III

  CE/MDR MDR 736172 Active Valid to Mar 2028

• AXS Infinity LS

  Class III

  CE/MDR MDR 736166 Expiring Valid to Oct 2027

See all devices from Stryker Neurovascular →