Home / 510(k) Clearances / K131144

510(k) K131144

AMECO SHEATH INTRODUCER by Ameco Medical Industries — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2013
Date Received
April 23, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Ameco Medical Industries

  • K152819 — Amecath Peripheral inserted Central Venous Catheter Sets (February 5, 2016)
  • 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 DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)