The following data is part of a premarket notification filed by Renal Solutions, Inc. with the FDA for Venofer Pump.
| Device ID | K103564 |
| 510k Number | K103564 |
| Device Name: | VENOFER PUMP |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | RENAL SOLUTIONS, INC. 770 COMMONWEALTH DR SUITE 101 Warrendale, PA 15086 |
| Contact | David Vanella |
| Correspondent | David Vanella RENAL SOLUTIONS, INC. 770 COMMONWEALTH DR SUITE 101 Warrendale, PA 15086 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2011-02-10 |
| Summary: | summary |