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510(k) K955002

MAHURKAR 8 FR DUAL LEMEN CATHETER by Quinton, Inc. — Product Code MPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1996
Date Received
November 1, 1995
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 Quinton, Inc.

  • K032038 — PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 (September 5, 2003)
  • K021906 — QUINTON Q-CATH, MODEL 000460 (September 4, 2002)
  • K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 (January 25, 2001)
  • K001492 — QUINTON Q-STRESS, MODEL 000483 (August 9, 2000)
  • K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) (March 6, 2000)
  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • K971397 — VIEWCATH 3-D CATHETER PULLBACK (August 25, 1997)
  • K964784 — SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) (August 13, 1997)
  • K964978 — VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) (May 21, 1997)
  • K961014 — QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH (July 31, 1996)

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)