The following data is part of a premarket notification filed by United Therapeutics Corporation with the FDA for Low Potassium Dextran Solution With Tris Diluent.
| Device ID | K153384 |
| 510k Number | K153384 |
| Device Name: | Low Potassium Dextran Solution With Tris Diluent |
| Classification | System, Perfusion, Kidney |
| Applicant | United Therapeutics Corporation 55 TW Alexander Drive, PO Box 14186 Research Triangle Park, NC 27709 |
| Contact | Rita Lee |
| Correspondent | Rita Lee United Therapeutics Corporation 55 TW Alexander Drive, PO Box 14186 Research Triangle Park, NC 27709 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2016-02-19 |
| Summary: | summary |