NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

MARVAO MEDICAL DEVICES, LTD.

The following data is part of a premarket notification filed by Marvao Medical Devices, Ltd. with the FDA for Nexsite 9fr Dual Lumen Critical Care Central Venous Catheter.

Pre-market Notification Details

Device IDK110627
510k NumberK110627
Device Name:NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET SUITE 7 Northboro,  MA  01532
ContactMarybeth Gamber
CorrespondentMarybeth Gamber
MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET SUITE 7 Northboro,  MA  01532
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-04
Decision Date2011-08-12
Summary:summary

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