NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)

Catheter, Hemodialysis, Implanted

MARVAO MEDICAL DEVICES, LTD.

The following data is part of a premarket notification filed by Marvao Medical Devices, Ltd. with the FDA for Nexsite Hd Hemodialysis Catheter For Long Term Use (28cm) Nexsite Hd Hemodialysis Catheter For Long Term Use (24cm).

Pre-market Notification Details

Device IDK121933
510k NumberK121933
Device Name:NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
ClassificationCatheter, Hemodialysis, Implanted
Applicant MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET SUITE 7 Northborough,  MA  01532
ContactMarybeth Gamber
CorrespondentMarybeth Gamber
MARVAO MEDICAL DEVICES, LTD. 368 WEST MAIN STREET SUITE 7 Northborough,  MA  01532
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-02
Decision Date2013-03-14
Summary:summary

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