The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage Therapeutic Plasma Exchange (tpe) Cartridge.
| Device ID | K143313 |
| 510k Number | K143313 |
| Device Name: | NxStage Therapeutic Plasma Exchange (TPE) Cartridge |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | NxStage Medical, Inc. 350 Merrimack Street Lawrence, MA 01843 |
| Contact | Randall J Covill |
| Correspondent | Randall J 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 | 2014-11-19 |
| Decision Date | 2015-03-20 |
| Summary: | summary |