510(k) DEN150049
DEN150049 is an FDA 510(k) premarket notification submitted by Concentric Medical, Inc. for the device "Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm". The FDA issued a decision of De Novo Granted on September 2, 2016. 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. Concentric Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 2, 2016
- Date Received
- October 26, 2015
- Clearance Type
- Direct
- 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.