Trevo Trak 21 Microcatheter— 510(k) K261889

Substantially Equivalent

Stryker Neurovascular

FDA 510(k) clearance K261889 for Trevo Trak 21 Microcatheter, Substantially Equivalent on 2026-07-01. Applicant: Stryker Neurovascular. Device class: 2.

Clearance details

Applicant
Stryker Neurovascular
Product code
Code QJP
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Fremont, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code QJP

product code QJP
Death
43
Injury
233
Malfunction
1,010
Total
1,286

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.