The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Navien Intracranial Support Catheter.
| Device ID | K161152 |
| 510k Number | K161152 |
| Device Name: | Navien Intracranial Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Ingrid Takeuchi |
| Correspondent | Jennifer Correa 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 | 2016-04-25 |
| Decision Date | 2016-10-12 |
| Summary: | summary |