The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Azur Pushable 18 & 35 System.
| Device ID | K130577 |
| 510k Number | K130577 |
| Device Name: | AZUR PUSHABLE 18 & 35 SYSTEM |
| 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 | 2013-03-05 |
| Decision Date | 2013-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810170017473 | K130577 | 000 |
| 10810170017466 | K130577 | 000 |
| 10810170017459 | K130577 | 000 |
| 10810170017442 | K130577 | 000 |
| 10810170017435 | K130577 | 000 |
| 10810170017428 | K130577 | 000 |
| 10810170017411 | K130577 | 000 |
| 10810170017404 | K130577 | 000 |
| 10810170014496 | K130577 | 000 |