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510(k) K140492

NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE by Marvao Medical Devices, Ltd. — Product Code MSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2014
Date Received
February 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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  • K161026 — NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 c (August 9, 2016)
  • K143567 — NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD (March 31, 2015)
  • K133796 — NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIAL (January 31, 2014)
  • K121933 — NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSI (March 14, 2013)
  • K110627 — NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER (August 12, 2011)

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