The following data is part of a premarket notification filed by Nxstage Medical, Inc with the FDA for Nxstage System One Plus.
| Device ID | K170469 |
| 510k Number | K170469 |
| Device Name: | NxStage System One Plus |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NxStage Medical, Inc 350 Merrimack Street Lawrence, MA 01843 |
| Contact | Randall Covill |
| Correspondent | Randall Covill NxStage Medical, Inc 350 Merrimack Street 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 | 2017-02-16 |
| Decision Date | 2017-05-09 |
| Summary: | summary |