The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Azur Detachable 35.
| Device ID | K122316 |
| 510k Number | K122316 |
| Device Name: | AZUR DETACHABLE 35 |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Contact | Cynthia Valenzuela |
| Correspondent | Cynthia Valenzuela 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 | 2012-08-01 |
| Decision Date | 2012-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170014390 | K122316 | 000 |
| 00810170014383 | K122316 | 000 |
| 00810170014376 | K122316 | 000 |
| 00810170014369 | K122316 | 000 |