The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Azur Cx Detachable 35 Coils.
| Device ID | K151358 |
| 510k Number | K151358 |
| Device Name: | AZUR CX Detachable 35 Coils |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-20 |
| Decision Date | 2015-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812636021102 | K151358 | 000 |
| 00812636021027 | K151358 | 000 |
| 00812636021034 | K151358 | 000 |
| 00812636021041 | K151358 | 000 |
| 00812636021058 | K151358 | 000 |
| 00812636021065 | K151358 | 000 |
| 00812636021072 | K151358 | 000 |
| 00812636021089 | K151358 | 000 |
| 00812636021096 | K151358 | 000 |
| 00812636021010 | K151358 | 000 |