K162524 is an FDA 510(k) clearance for the AZUR CX Detachable 18 Peripheral Coil System. This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on March 3, 2017, 175 days after receiving the submission on September 9, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K162524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2016 |
| Decision Date | March 03, 2017 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRD — Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |