The following data is part of a premarket notification filed by Micro Therapeutics, Inc D/b/a Ev3 Neurovascular with the FDA for Solitaire X Revascularization Device.
| Device ID | K203358 |
| 510k Number | K203358 |
| Device Name: | Solitaire X Revascularization Device |
| Classification | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Applicant | Micro Therapeutics, Inc D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Contact | Kevin Kong |
| Correspondent | Kevin Kong Micro Therapeutics, Inc D/b/a Ev3 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 | 2020-11-16 |
| Decision Date | 2021-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000367626 | K203358 | 000 |
| 00763000367619 | K203358 | 000 |