The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Solitare Platinum Revascularization Device.
| Device ID | K181186 |
| 510k Number | K181186 |
| Device Name: | Solitare Platinum 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 | Ryan Kenney |
| 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 | 2018-05-03 |
| Decision Date | 2018-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536034792 | K181186 | 000 |
| 00763000425333 | K181186 | 000 |
| 00763000425395 | K181186 | 000 |
| 00763000425456 | K181186 | 000 |
| 00763000425517 | K181186 | 000 |
| 00763000425579 | K181186 | 000 |
| 00847536034747 | K181186 | 000 |
| 00847536034754 | K181186 | 000 |
| 00847536034761 | K181186 | 000 |
| 00847536034778 | K181186 | 000 |
| 00847536034785 | K181186 | 000 |
| 00763000425272 | K181186 | 000 |