K120917 is an FDA 510(k) clearance for the HEADWAY DUO MICROCATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on August 2, 2012, 128 days after receiving the submission on March 27, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K120917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2012 |
| Decision Date | August 02, 2012 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |