The following data is part of a premarket notification filed by Medtronic Neurovascular with the FDA for Solitaire 2 And Solitaire Platinum Revascularization Device.
| Device ID | K181060 |
| 510k Number | K181060 |
| Device Name: | Solitaire 2 And Solitaire Platinum Revascularization Device |
| Classification | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Applicant | Medtronic Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Contact | Amnon Talmor |
| Correspondent | Amnon Talmor Medtronic Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Product Code | POL |
| CFR Regulation Number | 882.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-23 |
| Decision Date | 2018-08-24 |
| Summary: | summary |