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510(k) K110793

AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS by Ameco Medical Industries — Product Code MPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2011
Date Received
March 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Non-Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Ameco Medical Industries

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  • 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)

Other clearances for product code MPB

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  • K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurk (January 17, 2020)
  • K163458 — Zenysis Short-Term Dialysis Catheter (April 4, 2017)
  • K161504 — Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (January 6, 2017)
  • K153190 — Zenysis Short-Term Dialysis Catheter (January 5, 2016)
  • K122091 — COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO H (July 29, 2013)
  • K120674 — MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (April 4, 2012)
  • K102833 — DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS (November 18, 2011)