K112979 is an FDA 510(k) clearance for the ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE. This device is classified as a Guide, Wire, Catheter, Neurovasculature (Class II - Special Controls, product code MOF).
Submitted by Asahi Intecc Co., Ltd. (Santa Ana, US). The FDA issued a Cleared decision on December 1, 2011, 56 days after receiving the submission on October 6, 2011.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K112979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2011 |
| Decision Date | December 01, 2011 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MOF — Guide, Wire, Catheter, Neurovasculature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |