The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Solitaire 4 Revascularization Device.
| Device ID | K183022 |
| 510k Number | K183022 |
| Device Name: | Solitaire 4 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 | Helen Chow |
| Correspondent | Helen Chow 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 | 2018-11-01 |
| Decision Date | 2019-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000425739 | K183022 | 000 |
| 00763000425715 | K183022 | 000 |
| 00763000425692 | K183022 | 000 |
| 00763000425678 | K183022 | 000 |
| 00763000425654 | K183022 | 000 |
| 00763000425630 | K183022 | 000 |