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510(k) K022221

TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS by Deltec, Inc. — Product Code MPB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 30, 2003
Date Received
July 9, 2002
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 Deltec, Inc.

  • K031361 — CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP (May 23, 2003)
  • K030983 — TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X (April 25, 2003)
  • K021999 — GRIPPER PLUS NEEDLE (August 13, 2002)
  • K020655 — DELTEC INSULIN INFUSION PUMP AND ACCESSORIES (August 13, 2002)

Other clearances for product code MPB

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  • K200426 — Acute Dual Lumen Hemodialysis Catheter (December 24, 2020)
  • K192807 — Duo-Flow Side x Side Double Lumen Catheter (April 23, 2020)
  • 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)