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Trevo NXT ProVue Retriever

by Stryker Neurovascular 2 variants

510(k) K223305

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223305 Date29 Mar 2023ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1905-2024 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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
POL
Device Class
Class II
Regulation
21 CFR Part 882.5600
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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