The following data is part of a premarket notification filed by Asahi Kasei Medical Co., Ltd. with the FDA for Asahi Vie-u Series Dialyzer.
| Device ID | K162248 |
| 510k Number | K162248 |
| Device Name: | Asahi ViE-U Series Dialyzer |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | ASAHI KASEI MEDICAL CO., LTD. 1-105 KANDA JINBOCHO Chiyoda-ku, JP 101-8101 |
| Contact | Masaharu Aritomi |
| Correspondent | Megan Shackelford BOSTON BIOMEDICAL ASSOCIATES 100 CROWLEY DRIVE, SUITE 216 Marlborough, MA 01752 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-10 |
| Decision Date | 2017-05-03 |
| Summary: | summary |