The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for React 71 Catheter.
| Device ID | K182097 |
| 510k Number | K182097 |
| Device Name: | React 71 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 | 2018-08-03 |
| Decision Date | 2018-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536031784 | K182097 | 000 |
| 00847536044197 | K182097 | 000 |