Home / 510(k) Clearances / K152819

510(k) K152819

Amecath Peripheral inserted Central Venous Catheter Sets by Ameco Medical Industries — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2016
Date Received
September 28, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Ameco Medical Industries

  • K131144 — AMECO SHEATH INTRODUCER (August 15, 2013)
  • K131814 — AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER (July 26, 2013)
  • K123943 — AMECATH DUAL LUMEN HEMODIALYSIS CATHETER (April 2, 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 LJS

  • K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC (December 16, 2025)
  • K252792 — PM2™ System with ECGuide™ Connector (November 17, 2025)
  • K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (700013 (August 1, 2025)
  • K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr Hyd (July 1, 2025)
  • K243484 — PM2+ System and SmartPICC Stylet (May 29, 2025)
  • K241587 — pilot TLS (February 26, 2025)
  • K241910 — Neonav ECG Tip Location System (January 19, 2025)
  • K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001 (January 17, 2025)
  • K240486 — PM2 System and ECGuide Connector (September 8, 2024)
  • K233149 — CATHTONG III Tapered PICC Catheter (December 1, 2023)