K203358 is an FDA 510(k) clearance for the Solitaire X Revascularization Device. This device is classified as a Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (Class II - Special Controls, product code POL).
Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on March 1, 2021, 105 days after receiving the submission on November 16, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5600. 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..
| 510(k) Number | K203358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2020 |
| Decision Date | March 01, 2021 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | POL — Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5600 |
| Definition | 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. |