The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable 35.
| Device ID | K122543 |
| 510k Number | K122543 |
| Device Name: | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
| 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 | 2012-08-21 |
| Decision Date | 2012-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810170018784 | K122543 | 000 |
| 10810170018258 | K122543 | 000 |
| 10810170018241 | K122543 | 000 |
| 10810170018234 | K122543 | 000 |
| 10810170018227 | K122543 | 000 |
| 10810170018210 | K122543 | 000 |
| 10810170018203 | K122543 | 000 |
| 10810170018197 | K122543 | 000 |
| 10810170018180 | K122543 | 000 |
| 10810170018173 | K122543 | 000 |
| 10810170018166 | K122543 | 000 |
| 10810170018159 | K122543 | 000 |
| 10810170018142 | K122543 | 000 |
| 10810170018135 | K122543 | 000 |
| 10810170018128 | K122543 | 000 |
| 10810170018111 | K122543 | 000 |
| 10810170018104 | K122543 | 000 |
| 10810170018265 | K122543 | 000 |
| 10810170018272 | K122543 | 000 |
| 10810170018777 | K122543 | 000 |
| 10810170018760 | K122543 | 000 |
| 10810170018753 | K122543 | 000 |
| 10810170018746 | K122543 | 000 |
| 10810170018739 | K122543 | 000 |
| 10810170018722 | K122543 | 000 |
| 10810170018715 | K122543 | 000 |
| 10810170018708 | K122543 | 000 |
| 10810170018692 | K122543 | 000 |
| 10810170018685 | K122543 | 000 |
| 10810170018678 | K122543 | 000 |
| 10810170018661 | K122543 | 000 |
| 10810170018654 | K122543 | 000 |
| 10810170018647 | K122543 | 000 |
| 10810170018630 | K122543 | 000 |
| 10810170018289 | K122543 | 000 |
| 10810170018098 | K122543 | 000 |