The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Combiset Smartech Hemodialysis Blood Tubing Set With Attached Priming Set And Integrated Crit-line Technology, Combiset Smartech Hemodialysis Blood Tubing Set With Attached Priming Set And Intergrated Crit-line Technology, No Heparin Line.
| Device ID | K201207 |
| 510k Number | K201207 |
| Device Name: | CombiSet SMARTECH Hemodialysis Blood Tubing Set With Attached Priming Set And Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set With Attached Priming Set And Intergrated Crit-Line Technology, No Heparin Line |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-05 |
| Decision Date | 2020-09-18 |