The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Azur Pure Peripheral Coil System, Pushable 35.
| Device ID | K133626 |
| 510k Number | K133626 |
| Device Name: | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Contact | Laraine Pangelina |
| Correspondent | Laraine Pangelina MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-26 |
| Decision Date | 2013-12-20 |
| Summary: | summary |