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510(k) K161026

NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) by Marvao Medical Devices, Ltd. — Product Code MSD

K161026 is an FDA 510(k) premarket notification submitted by Marvao Medical Devices, Ltd. for the device "NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)". The FDA issued a decision of Substantially Equivalent (kit) on August 9, 2016. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Marvao Medical Devices, Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
August 9, 2016
Date Received
April 12, 2016
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

Other clearances by Marvao Medical Devices, Ltd.

  • K220632 — Boss Crossing Support Catheter (June 2, 2022)
  • K173805 — NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite (February 8, 2018)
  • K171571 — NexSite HD, Hemodialysis Step Tip Catheter (60cm) (November 30, 2017)
  • K143567 — NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD (March 31, 2015)
  • K140492 — NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE (November 13, 2014)
  • 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)

Other clearances for product code MSD

  • K241581 — Hemodialysis Catheter (May 16, 2025)
  • K210461 — End Cap (September 14, 2021)
  • K203575 — GlidePath Retro Long-Term Hemodialysis Catheter (July 1, 2021)
  • K211410 — GlidePath 13F Long-Term Hemodialysis Catheter (June 4, 2021)
  • K203767 — Pristine Long-Term Hemodialysis Catheter (April 2, 2021)
  • K202150 — GlidePath 7.5F Long-Term Dialysis Catheter (November 18, 2020)
  • K202176 — Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (September 3, 2020)
  • K200627 — GlidePath 10F Long-Term Dialysis Catheter (June 22, 2020)
  • K190527 — GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Cath (March 5, 2020)
  • K182443 — Pristine Hemodialysis Catheter (May 31, 2019)

FDA data resources