The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Neurovascular Guide Wire: Asahi Chikai Black 14 Soft Tip.
| Device ID | K161912 |
| 510k Number | K161912 |
| Device Name: | ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Black 14 Soft Tip |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | ASAHI INTECC CO., LTD. 1703 Wakita-cho, Moriyama-ku Nagoya, JP 463-0024 |
| Contact | Yasuyuki Kawahara |
| Correspondent | Candace Cederman Cardiomed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-12 |
| Decision Date | 2016-10-14 |
| Summary: | summary |