510(k) clearances for Catheter, Hemodialysis, Non-implanted

38 on file

Medical Components, Inc.Aug 12, 2025
K250836 · 14F Duo-Flow® Side X Side Double Lumen Catheter
Health Line International CorporationDec 24, 2020
K200426 · Acute Dual Lumen Hemodialysis Catheter
Medical Components, Inc. (dba MedComp)Apr 23, 2020
K192807 · Duo-Flow Side x Side Double Lumen Catheter
Covidien, LLCJan 17, 2020
K192302 · Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
C.R. Bard, Inc.Apr 4, 2017
K163458 · Zenysis Short-Term Dialysis Catheter
Cook IncorporatedJan 6, 2017
K161504 · Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
C.R. Bard, Inc.Jan 5, 2016
K153190 · Zenysis Short-Term Dialysis Catheter
Cook, Inc.Jul 29, 2013
K122091 · COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
CovidienApr 4, 2012
K120674 · MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
Ameco Medical IndustriesDec 16, 2011
K110793 · AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
Foshan Nanhai Bai HE Medical Technology Co., Ltd.Nov 18, 2011
K102833 · DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
Gambro Renal Products, Inc.Dec 21, 2010
K100451 · GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
C.R. Bard, Inc.Feb 12, 2009
K090102 · NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
Nipro Medical CorporationSep 7, 2007
K071145 · NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
Novosci Corp.Jul 27, 2007
K063355 · D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW
Jms North America Corp.May 22, 2007
K070234 · JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS
Gambro Renal ProductsNov 1, 2004
K040301 · GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
C.R. Bard, Inc.Jul 30, 2003
K030268 · NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS
The Kendall CompanyMay 13, 2003
K030209 · MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
Deltec, Inc.Jan 30, 2003
K022221 · TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
C.R. Bard, Inc.Apr 13, 2001
K010778 · NIAGARA SLIM-CATH
Keystone MedicalSep 25, 2000
K001958 · KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH
Arrow Intl., Inc.Sep 14, 2000
K993933 · 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
Medical Components, Inc.Nov 10, 1999
K991320 · MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
Medical Components, Inc.Jun 10, 1999
K980438 · 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT
Medical Components, Inc.Jun 8, 1999
K983511 · SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
Arrow Intl., Inc.May 26, 1999
K991431 · 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
Arrow Intl., Inc.May 18, 1999
K984022 · PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
Medical Components, Inc.Apr 15, 1999
K974236 · MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
Vas-Cath, Inc.Aug 19, 1997
K965178 · NIAGARA DUAL LUMEN CATHETER
Kendall Healthcare Products Co. Div.Of Tyco HealthMar 18, 1997
K963446 · KENDALL DUAL LUMEN CATHETER
B.Braun Medical, Inc.Sep 17, 1996
K952660 · BRAUN HEMODIALYSIS CATHETER
Quinton, Inc.Sep 13, 1996
K955002 · MAHURKAR 8 FR DUAL LEMEN CATHETER
Medical Components, Inc.Sep 25, 1995
K923691 · TWIN SILICONE CATHETER
Quinton, Inc.Jan 29, 1990
K896252 · MODIFIED QUINTON SINGLE LUMEN CATHETER
Quinton, Inc.Jun 8, 1989
K893188 · QUINTON SINGLE LUMEN CATHETER
Quinton, Inc.Feb 22, 1988
K880583 · MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH
Quinton, Inc.Apr 29, 1987
K871360 · 10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE