The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Neurovascular Guide Wire Chikai X 014 Soft.
| Device ID | K191714 |
| 510k Number | K191714 |
| Device Name: | ASAHI Neurovascular Guide Wire CHIKAI X 014 Soft |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | Asahi Intecc Co., Ltd. 3-100 Akatsuki-cho Seto, JP 489-0071 |
| Contact | Yasuyuki Kawahara |
| Correspondent | Cynthia Valenzuela Asahi Intecc USA, Inc. 3002 Dow Ave, Suite 212 Tustin, CA 92780 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-26 |
| Decision Date | 2019-07-26 |
| Summary: | summary |