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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K143567
Device Name NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)
Applicant
Marvao Medical Devices, Ltd.
Gmit Innovation In Business Centre, Dublin Rd.
Galway,  IE
Applicant Contact CHRISTOPHER DAVEY
Correspondent
Boston Biomedical Associates
100 Crowley Dr.
Suite 216
Malborough,  MA  01752
Correspondent Contact CHRISTINE NICHOLS
Regulation Number876.5540
Classification Product Code
MSD  
Date Received12/16/2014
Decision Date 03/31/2015
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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