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510(k) K200426

Acute Dual Lumen Hemodialysis Catheter by Health Line International Corporation — Product Code MPB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 24, 2020
Date Received
February 21, 2020
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 Health Line International Corporation

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  • K160448 — ARTLINE (July 12, 2016)
  • K140270 — NEXUS MIDLINE CT CATHETER (August 20, 2014)
  • K130851 — CASCADE HEMODIALYSIS/APHERESIS CATHETER (January 9, 2014)
  • K130034 — UNI-PICC (March 8, 2013)
  • K120548 — HLIC NEEDLE-LESS VALVE (May 4, 2012)
  • K101329 — SYNERGY CT PICC (August 19, 2010)
  • K060352 — HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS (May 31, 2006)

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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)
  • K110793 — AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KI (December 16, 2011)
  • K102833 — DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS (November 18, 2011)