Catheter, Hemodialysis, Non-Implanted

FDA product code MPB · 38 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5540
Review panel: GU
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1987-04-29 – 2025-08-12

MPB 2025-08-12

14F Duo-Flow® Side X Side Double Lumen Catheter

Applicant Medical Components, Inc.

K number K250836

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MPB 2020-12-24

Acute Dual Lumen Hemodialysis Catheter

Applicant Health Line International Corporation

K number K200426

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MPB 2020-04-23

Duo-Flow Side x Side Double Lumen Catheter

Applicant Medical Components, Inc. (dba MedComp)

K number K192807

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MPB 2020-01-17

Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter

Applicant Covidien, LLC

K number K192302

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MPB 2017-04-04

Zenysis Short-Term Dialysis Catheter

Applicant C.R. Bard, Inc.

K number K163458

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MPB 2017-01-06

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray

Applicant Cook Incorporated

K number K161504

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MPB 2016-01-05

Zenysis Short-Term Dialysis Catheter

Applicant C.R. Bard, Inc.

K number K153190

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MPB 2013-07-29

COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

Applicant Cook, Inc.

K number K122091

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MPB 2012-04-04

MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER

Applicant Covidien

K number K120674

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MPB 2011-12-16

AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS

Applicant Ameco Medical Industries

K number K110793

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MPB 2011-11-18

DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS

Applicant Foshan Nanhai Bai HE Medical Technology Co., Ltd.

K number K102833

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MPB 2010-12-21

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

Applicant Gambro Renal Products, Inc.

K number K100451

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MPB 2009-02-12

NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS

Applicant C.R. Bard, Inc.

K number K090102

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MPB 2007-09-07

NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE

Applicant Nipro Medical Corporation

K number K071145

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MPB 2007-07-27

D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW

Applicant Novosci Corp.

K number K063355

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MPB 2007-05-22

JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS

Applicant Jms North America Corp.

K number K070234

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MPB 2004-11-01

GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A

Applicant Gambro Renal Products

K number K040301

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MPB 2003-07-30

NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS

Applicant C.R. Bard, Inc.

K number K030268

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MPB 2003-05-13

MAHURKAR OPLUS CATHETER, MODEL 13.5 FR

Applicant The Kendall Company

K number K030209

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MPB 2003-01-30

TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS

Applicant Deltec, Inc.

K number K022221

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MPB 2001-04-13

NIAGARA SLIM-CATH

Applicant C.R. Bard, Inc.

K number K010778

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MPB 2000-09-25

KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH

Applicant Keystone Medical

K number K001958

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MPB 2000-09-14

14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO

Applicant Arrow Intl., Inc.

K number K993933

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MPB 1999-11-10

MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN

Applicant Medical Components, Inc.

K number K991320

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MPB 1999-06-10

11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT

Applicant Medical Components, Inc.

K number K980438

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MPB 1999-06-08

SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH

Applicant Medical Components, Inc.

K number K983511

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MPB 1999-05-26

14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT

Applicant Arrow Intl., Inc.

K number K991431

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MPB 1999-05-18

PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT

Applicant Arrow Intl., Inc.

K number K984022

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MPB 1999-04-15

MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB

Applicant Medical Components, Inc.

K number K974236

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MPB 1997-08-19

NIAGARA DUAL LUMEN CATHETER

Applicant Vas-Cath, Inc.

K number K965178

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MPB 1997-03-18

KENDALL DUAL LUMEN CATHETER

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K963446

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MPB 1996-09-17

BRAUN HEMODIALYSIS CATHETER

Applicant B.Braun Medical, Inc.

K number K952660

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MPB 1996-09-13

MAHURKAR 8 FR DUAL LEMEN CATHETER

Applicant Quinton, Inc.

K number K955002

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MPB 1995-09-25

TWIN SILICONE CATHETER

Applicant Medical Components, Inc.

K number K923691

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MPB 1990-01-29

MODIFIED QUINTON SINGLE LUMEN CATHETER

Applicant Quinton, Inc.

K number K896252

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MPB 1989-06-08

QUINTON SINGLE LUMEN CATHETER

Applicant Quinton, Inc.

K number K893188

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MPB 1988-02-22

MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH

Applicant Quinton, Inc.

K number K880583

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MPB 1987-04-29

10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE

Applicant Quinton, Inc.

K number K871360

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