The following data is part of a premarket notification filed by Microvention, Inc with the FDA for Azur Cx Detachable 18 Peripheral Coil System.
| Device ID | K162524 |
| 510k Number | K162524 |
| Device Name: | AZUR CX Detachable 18 Peripheral Coil System |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | MicroVention, Inc 1311 Valencia Avenue Tustin, CA 92780 |
| Contact | Laraine Pangelina |
| Correspondent | Laraine Pangelina MicroVention, Inc 1311 Valencia Avenue Tustin, CA 92780 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-09 |
| Decision Date | 2017-03-03 |
| Summary: | summary |