The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Azur Peripheral Hydrocoil Endovascular Embolization System-detachable 35, Models 45-450405, 45-450410, 45-450610.
| Device ID | K093002 |
| 510k Number | K093002 |
| Device Name: | AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong 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 | 2009-09-28 |
| Decision Date | 2009-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170015045 | K093002 | 000 |
| 00810170014888 | K093002 | 000 |
| 00810170014895 | K093002 | 000 |
| 00810170014901 | K093002 | 000 |
| 00810170014918 | K093002 | 000 |
| 00810170014925 | K093002 | 000 |
| 00810170014932 | K093002 | 000 |
| 00810170014949 | K093002 | 000 |
| 00810170014956 | K093002 | 000 |
| 00810170014963 | K093002 | 000 |
| 00810170014970 | K093002 | 000 |
| 00810170014987 | K093002 | 000 |
| 00810170014994 | K093002 | 000 |
| 00810170015007 | K093002 | 000 |
| 00810170015014 | K093002 | 000 |
| 00810170015021 | K093002 | 000 |
| 00810170015038 | K093002 | 000 |
| 10810170012126 | K093002 | 000 |