The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Solitaire Platinum Revascularization Device.
| Device ID | K161879 |
| 510k Number | K161879 |
| Device Name: | Solitaire Platinum Revascularization Device |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Contact | Ryan Kenney |
| Correspondent | Ryan Kenney Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-08 |
| Decision Date | 2016-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536033979 | K161879 | 000 |
| 00847536033962 | K161879 | 000 |
| 00847536027060 | K161879 | 000 |
| 00847536027053 | K161879 | 000 |