The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for React 68 Catheter.
| Device ID | K180715 |
| 510k Number | K180715 |
| Device Name: | React 68 Catheter |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-19 |
| Decision Date | 2018-07-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000270759 | K180715 | 000 |
| 00763000270407 | K180715 | 000 |
| 00763000270414 | K180715 | 000 |
| 00763000270438 | K180715 | 000 |
| 00763000270476 | K180715 | 000 |
| 00763000270483 | K180715 | 000 |
| 00763000270490 | K180715 | 000 |
| 00763000270506 | K180715 | 000 |
| 00763000270513 | K180715 | 000 |
| 00763000270728 | K180715 | 000 |
| 00763000270735 | K180715 | 000 |
| 00763000270742 | K180715 | 000 |
| 00847536041967 | K180715 | 000 |