The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Azur Peripheral Hydrocoil Endovascular Embolization System.
| Device ID | K091882 |
| 510k Number | K091882 |
| Device Name: | AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-24 |
| Decision Date | 2009-07-08 |
| Summary: | summary |