Trevo Trak 21 Microcatheter— 510(k) K211594
Substantially EquivalentStryker Neurovascular
FDA 510(k) clearance K211594 for Trevo Trak 21 Microcatheter, Substantially Equivalent on 2021-11-26. 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
Recent devices under product code QJP
view allMore clearances from Stryker Neurovascular
view all- K261889 — Trevo Trak 21 Microcatheter
- K253032 — AXS Lift Intracranial Base Catheter
- K252694 — Target Detachable Coil
- K251832 — InZone IST Detachment System; IZDS Connecting Cable
- K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
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 →
Recalls naming K211594
K-number listed on FDA's recall record- Z-0021-2025 — The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
- Z-1906-2024 — Trevo Trak 21 Microcatheter, Catalog: 90338
- Z-1085-2024 — Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211594.
Data sourced from openFDA. This site is unofficial and independent of the FDA.