The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Azur Cx Detachable 18.
| Device ID | K123384 |
| 510k Number | K123384 |
| Device Name: | AZUR CX DETACHABLE 18 |
| 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 | 2012-11-02 |
| Decision Date | 2012-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170018404 | K123384 | 000 |
| 00810170017582 | K123384 | 000 |
| 00810170017575 | K123384 | 000 |
| 00810170017568 | K123384 | 000 |
| 00810170017551 | K123384 | 000 |
| 00810170017544 | K123384 | 000 |
| 00810170017537 | K123384 | 000 |
| 00810170017520 | K123384 | 000 |
| 00810170017513 | K123384 | 000 |
| 00810170017506 | K123384 | 000 |
| 00810170017490 | K123384 | 000 |
| 00810170017599 | K123384 | 000 |
| 00810170018299 | K123384 | 000 |
| 00810170018398 | K123384 | 000 |
| 00810170018381 | K123384 | 000 |
| 00810170018374 | K123384 | 000 |
| 00810170018367 | K123384 | 000 |
| 00810170018350 | K123384 | 000 |
| 00810170018343 | K123384 | 000 |
| 00810170018336 | K123384 | 000 |
| 00810170018329 | K123384 | 000 |
| 00810170018312 | K123384 | 000 |
| 00810170018305 | K123384 | 000 |
| 00810170017483 | K123384 | 000 |