CAREline Airless Hemodialysis Blood Tubing Sets

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 Careline Airless Hemodialysis Blood Tubing Sets.

Pre-market Notification Details

Device IDK172238
510k NumberK172238
Device Name:CAREline Airless Hemodialysis Blood Tubing Sets
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 Received2017-07-26
Decision Date2017-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840861100415 K172238 000
10840861100405 K172238 000

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