The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Silverway.
| Device ID | K183062 |
| 510k Number | K183062 |
| Device Name: | ASAHI Silverway |
| Classification | Wire, Guide, Catheter |
| Applicant | Asahi Intecc Co., LTD. 1703 Wakita-cho, Moriyama-ku Nagoya, JP 463-0024 |
| Contact | Yasuyuki Kawahara |
| Correspondent | Candace Cederman CardioMed Device Consultants, LLC 1783 Forest Drive, #254 Annapolis, MD 21401 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-05 |
| Decision Date | 2019-07-01 |