The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Neurovasulature Guide Wire: Asahi Chikai Black 18 Soft Tip.
| Device ID | K171613 |
| 510k Number | K171613 |
| Device Name: | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI Black 18 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 | 2017-06-01 |
| Decision Date | 2017-07-01 |
| Summary: | summary |