Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K171571
Device Name NexSite HD, Hemodialysis Step Tip Catheter (60cm)
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
Marlborough,  MA  01752
Correspondent Contact Mary P LeGraw
Regulation Number876.5540
Classification Product Code
MSD  
Date Received05/30/2017
Decision Date 11/30/2017
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-