Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter

Catheter, Hemodialysis, Non-implanted

Covidien, Llc

The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter.

Pre-market Notification Details

Device IDK192302
510k NumberK192302
Device Name:Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
ClassificationCatheter, Hemodialysis, Non-implanted
Applicant Covidien, Llc 15 Hampshire Street Mansfield,  MA  02048
ContactCarol S Ming
CorrespondentCarol S Ming
Covidien, Llc 15 Hampshire Street Mansfield,  MA  02048
Product CodeMPB  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-08-23
Decision Date2020-01-17

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