The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Azur Detachable 35 Platinum Coil System.
| Device ID | K111307 |
| 510k Number | K111307 |
| Device Name: | AZUR DETACHABLE 35 PLATINUM COIL SYSTEM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-10 |
| Decision Date | 2011-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170016158 | K111307 | 000 |
| 00810170016141 | K111307 | 000 |
| 00810170016134 | K111307 | 000 |
| 00810170016127 | K111307 | 000 |
| 00810170016110 | K111307 | 000 |
| 00810170016103 | K111307 | 000 |
| 00810170016097 | K111307 | 000 |