The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage System One Low Volume Cartridge Express.
| Device ID | K123395 |
| 510k Number | K123395 |
| Device Name: | NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NXSTAGE MEDICAL, INC. 350 Merrimack St Lawrence, MA 01843 |
| Contact | Mary Lou Stroumbos |
| Correspondent | Mary Lou Stroumbos NXSTAGE MEDICAL, INC. 350 Merrimack St Lawrence, MA 01843 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-05 |
| Decision Date | 2013-03-07 |
| Summary: | summary |