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510(k) K123943

AMECATH DUAL LUMEN HEMODIALYSIS CATHETER by Ameco Medical Industries — Product Code MSD

K123943 is an FDA 510(k) premarket notification submitted by Ameco Medical Industries for the device "AMECATH DUAL LUMEN HEMODIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent on April 2, 2013. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Ameco Medical Industries has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2013
Date Received
December 20, 2012
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 Ameco Medical Industries

  • K152819 — Amecath Peripheral inserted Central Venous Catheter Sets (February 5, 2016)
  • K131144 — AMECO SHEATH INTRODUCER (August 15, 2013)
  • K131814 — AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER (July 26, 2013)
  • K110794 — AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZA (December 21, 2011)
  • K110793 — AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KI (December 16, 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