The following data is part of a premarket notification filed by Renal Solutions Inc. with the FDA for Venofer Pump.
| Device ID | K121497 |
| 510k Number | K121497 |
| Device Name: | VENOFER PUMP |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | RENAL SOLUTIONS INC. 770 COMMONWEALTH DRIVE SUITE 101 Warrendale, PA 15086 |
| Contact | David Vanella |
| Correspondent | David Vanella RENAL SOLUTIONS INC. 770 COMMONWEALTH DRIVE SUITE 101 Warrendale, PA 15086 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-21 |
| Decision Date | 2012-08-17 |
| Summary: | summary |