The following data is part of a premarket notification filed by Microvention Inc. with the FDA for Azur Vascular Plug.
| Device ID | K191680 |
| 510k Number | K191680 |
| Device Name: | AZUR Vascular Plug |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | MicroVention Inc. 35 Enterprise Aliso Viejo, CA 92656 |
| Contact | Ganesh Balachander |
| Correspondent | Ganesh Balachander MicroVention Inc. 35 Enterprise Aliso Viejo, CA 92656 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-24 |
| Decision Date | 2020-03-20 |