Home / 510(k) Clearances / K131260

510(k) K131260

NMI DIALYSIS CATHETER by Navilyst Medical, Inc. — Product Code MSD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
February 14, 2014
Date Received
May 2, 2013
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 Navilyst Medical, Inc.

  • K163452 — PICC Maximal Barrier Nursing Kit (February 3, 2017)
  • K161866 — BioFlo Midline Catheter (September 8, 2016)
  • K151239 — NMI DUAL PORT II (June 6, 2016)
  • K153228 — NMI Port, NMI Port II (December 4, 2015)
  • K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage (September 24, 2015)
  • K152409 — Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC (September 24, 2015)
  • K150407 — BioFlo Midline Catheter (May 15, 2015)
  • K150527 — Xcela Power Injectable PICC (March 31, 2015)
  • K150448 — NMI PICC III and NMI PICC IV (March 19, 2015)
  • K142616 — PICC Maximal Barrier Nursing Kit (October 14, 2014)

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)