The following data is part of a premarket notification filed by Asahi Kasei Medical Co., Ltd. with the FDA for Asahi Rexeed-sx/lx Series Dialyzer.
| Device ID | K121409 |
| 510k Number | K121409 |
| Device Name: | ASAHI REXEED-SX/LX SERIES DIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | ASAHI KASEI MEDICAL CO., LTD. 154 MAIN STREET, STE 2 Charlestown, NH 03603 |
| Contact | Patsy Trisler |
| Correspondent | Patsy Trisler ASAHI KASEI MEDICAL CO., LTD. 154 MAIN STREET, STE 2 Charlestown, NH 03603 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-11 |
| Decision Date | 2013-02-06 |
| Summary: | summary |