The following data is part of a premarket notification filed by Microtherapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Reverse 021 Micro Catheter, Reverse 027 Micro Catheter.
| Device ID | K171268 |
| 510k Number | K171268 |
| Device Name: | Reverse 021 Micro Catheter, Reverse 027 Micro Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | MicroTherapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Contact | Eric Elliott |
| Correspondent | Eric Elliott MicroTherapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Product Code | DQY |
| Subsequent Product Code | DQO |
| Subsequent Product Code | KRA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-01 |
| Decision Date | 2017-05-31 |
| Summary: | summary |