K130577 is an FDA 510(k) clearance for the AZUR PUSHABLE 18 & 35 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 June 17, 2013, 104 days after receiving the submission on March 5, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K130577 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2013 |
| Decision Date | June 17, 2013 |
| Days to Decision | 104 days |
| Submission Type | Special |
| 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 |