The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire.
| Device ID | K193548 |
| 510k Number | K193548 |
| Device Name: | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000294120 | K193548 | 000 |
| 00763000294113 | K193548 | 000 |