The following data is part of a premarket notification filed by Micro Therapeuatics, Inc. D/b/a Ev3 Neurovascular with the FDA for Rebar Micro Catheter.
| Device ID | K210114 |
| 510k Number | K210114 |
| Device Name: | Rebar Micro Catheter |
| Classification | Catheter, Continuous Flush |
| Applicant | Micro Therapeuatics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Contact | Catherine Chiou |
| Correspondent | Catherine Chiou Micro Therapeuatics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000539375 | K210114 | 000 |
| 00763000539368 | K210114 | 000 |
| 00763000539351 | K210114 | 000 |
| 00763000539344 | K210114 | 000 |
| 00763000539337 | K210114 | 000 |