510(k) K210502
K210502 is an FDA 510(k) premarket notification submitted by Stryker Neurovascular for the device "Trevo NXT ProVue Retriever". The FDA issued a decision of Substantially Equivalent on August 27, 2021. The device falls under product code POL (Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment), a Class II device regulated under 21 CFR 882.5600. Stryker Neurovascular has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2021
- Date Received
- February 22, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
- Device Class
- Class II
- Regulation Number
- 882.5600
- Review Panel
- NE
- Submission Type
A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.