Modified Concentirc Microcatheter

510(k) K113260

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK113260	Date9 Mar 2012Cleared	StatusActive

5 recalls · 1 ongoing · FDA

- 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.
- Terminated Z-0347-2018 FDA Class II initiated 28 Nov 2017 on shared 510(k) K113260
Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
3 recalls, same reason
- Terminated Z-0276-2018 FDA Class II initiated 3 Nov 2017 on shared 510(k) K113260
- Terminated Z-0275-2018 FDA Class II initiated 3 Nov 2017 on shared 510(k) K113260
- Terminated Z-0277-2018 FDA Class II initiated 3 Nov 2017 on shared 510(k) K113260
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)