The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Azur Detachable 18.
| Device ID | K120630 |
| 510k Number | K120630 |
| Device Name: | AZUR DETACHABLE 18 |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
| Contact | Cynthia Valenzuela |
| Correspondent | Cynthia Valenzuela MICRO VENTION, INC. 1311 VALENCIA AVENUE 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 | 2012-03-01 |
| Decision Date | 2012-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170017865 | K120630 | 000 |
| 00810170017858 | K120630 | 000 |
| 00810170017841 | K120630 | 000 |
| 00810170016400 | K120630 | 000 |
| 00810170016394 | K120630 | 000 |
| 00810170016387 | K120630 | 000 |