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

Accessories, Blood Circuit, Hemodialysis

Fresenius Medical Care Renal Therapies Group, LLC

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.

Pre-market Notification Details

Device IDK201207
510k NumberK201207
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
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
ContactDenise Oppermann
CorrespondentDenise Oppermann
Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-05
Decision Date2020-09-18

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