The following data is part of a premarket notification filed by Micro Therapeutics, Lnc. D/b/a Ev3 Neurovascular with the FDA for Phenom Catheters.
| Device ID | K210230 |
| 510k Number | K210230 |
| Device Name: | Phenom Catheters |
| Classification | Catheter, Percutaneous |
| Applicant | Micro Therapeutics, Lnc. D/b/a Ev3 Neurovascular 9775 Toledo Way Lrvine, CA 92618 |
| Contact | Prerana Gurubasavaraj |
| Correspondent | Prerana Gurubasavaraj Micro Therapeutics, Lnc. D/b/a Ev3 Neurovascular 9775 Toledo Way Lrvine, CA 92618 |
| Product Code | DQY |
| Subsequent Product Code | KRA |
| Subsequent Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-28 |
| Decision Date | 2021-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000399733 | K210230 | 000 |
| 00763000399658 | K210230 | 000 |
| 00763000399665 | K210230 | 000 |
| 00763000399672 | K210230 | 000 |
| 00763000399689 | K210230 | 000 |
| 00763000399696 | K210230 | 000 |
| 00763000399702 | K210230 | 000 |
| 00763000399719 | K210230 | 000 |
| 00763000399726 | K210230 | 000 |
| 00763000399641 | K210230 | 000 |