The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Sasuke.
| Device ID | K182844 |
| 510k Number | K182844 |
| Device Name: | ASAHI SASUKE |
| Classification | Catheter, Percutaneous |
| Applicant | Asahi Intecc Co., Ltd. 3-100 Akatsuki-cho Seto, JP 489-0071 |
| Contact | Yasuyuki Kawahara |
| Correspondent | Candace Cederman CardioMed Device Consultants, LLC 1783 Forest Drive #254 Annapolis, MD 21401 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-09 |
| Decision Date | 2019-06-22 |