The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Chikai 10 Neurovascular Guide Wire.
| Device ID | K112979 |
| 510k Number | K112979 |
| Device Name: | ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | ASAHI INTECC CO., LTD. 2500 RED HILL AVE, SUITE 210 Santa Ana, CA 92705 |
| Contact | Yoshi Terai |
| Correspondent | Yoshi Terai ASAHI INTECC CO., LTD. 2500 RED HILL AVE, SUITE 210 Santa Ana, CA 92705 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-06 |
| Decision Date | 2011-12-01 |
| Summary: | summary |