The following data is part of a premarket notification filed by Asahi Intecc Co., Ltd. with the FDA for Asahi Astato Xs 40.
| Device ID | K153443 |
| 510k Number | K153443 |
| Device Name: | ASAHI Astato XS 40 |
| Classification | Wire, Guide, Catheter |
| Applicant | ASAHI INTECC CO., LTD. 1703 WAKITA-CHO, MORIYAMA-KU Nagoya, JP 463-0024 |
| Contact | Yoshihiko Fukui |
| Correspondent | Candace Cederman CARDIOMED DEVICE CONSULTANTS, LLC 5523 RESEARCH PARK DRIVE SUITE 205 Baltimore, MD 21228 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-27 |
| Decision Date | 2016-02-25 |
| Summary: | summary |