The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (solitaire Revascularization Device).
| Device ID | K181807 |
| 510k Number | K181807 |
| Device Name: | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire 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 | Jennifer Correa |
| 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 | 2018-07-06 |
| Decision Date | 2019-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536034730 | K181807 | 000 |
| 00847536034723 | K181807 | 000 |
| 00847536034716 | K181807 | 000 |
| 00847536034709 | K181807 | 000 |
| 00847536034693 | K181807 | 000 |
| 00847536034686 | K181807 | 000 |