The following data is part of a premarket notification filed by Asahi Kasei Medical Co., Ltd. with the FDA for Asahi Rexeed-s Series Dialyzer.
| Device ID | K153344 |
| 510k Number | K153344 |
| Device Name: | Asahi REXEED-S 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 | Hidenobu Nakazawa |
| Correspondent | Patsy Trisler Qserve Group US, Inc. 5600 Wisconsin Avenue, #509 Chevy Chase, MD 20815 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-19 |
| Decision Date | 2015-12-17 |
| Summary: | summary |