510(k) K181186
K181186 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular for the device "Solitare Platinum Revascularization Device". The FDA issued a decision of Substantially Equivalent on October 25, 2018. 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. Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2018
- Date Received
- May 3, 2018
- 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.