Product Code: MPB FDA class 2 21 CFR 876.5540

Catheter, Hemodialysis, Non-Implanted

Gastroenterology, Urology

The Non-Implanted Hemodialysis Catheter is a urology device inserted into a large vein (such as the jugular or subclavian) to provide temporary vascular access for hemodialysis in patients with acute or chronic kidney failure. Classified as FDA Class 2 under 21 CFR 876.5540, it requires 510(k) premarket notification. The product code is MPB, and it carries a life-sustaining support flag given its critical role in patients dependent on dialysis.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MPB
Device Class: FDA class 2
Regulation Number: 876.5540
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250836	14F Duo-Flow® Side X Side Double Lumen Catheter	Aug 12, 2025	Substantially Equivalent	Medical Components, Inc.
K200426	Acute Dual Lumen Hemodialysis Catheter	Dec 24, 2020	Unknown	Health Line International Corporation
K192807	Duo-Flow Side x Side Double Lumen Catheter	Apr 23, 2020	Substantially Equivalent	Medical Components, Inc. (dba MedComp)
K192302	Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter	Jan 17, 2020	Unknown	Covidien, LLC
K163458	Zenysis Short-Term Dialysis Catheter	Apr 04, 2017	Unknown	C.R. Bard, Inc.
K161504	Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray	Jan 06, 2017	Unknown	Cook Incorporated
K153190	Zenysis Short-Term Dialysis Catheter	Jan 05, 2016	Substantially Equivalent	C.R. Bard, Inc.
K122091	COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY	Jul 29, 2013	Unknown	Cook, Inc.
K120674	MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER	Apr 04, 2012	Unknown	Covidien
K110793	AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS	Dec 16, 2011	Substantially Equivalent	Ameco Medical Industries
K102833	DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS	Nov 18, 2011	Substantially Equivalent	Foshan Nanhai Bai HE Medical Technology Co., Ltd.
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	Dec 21, 2010	Substantially Equivalent	Gambro Renal Products, Inc.
K090102	NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS	Feb 12, 2009	Unknown	C.R. Bard, Inc.
K071145	NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE	Sep 07, 2007	Substantially Equivalent	Nipro Medical Corporation
K063355	D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW	Jul 27, 2007	Unknown	Novosci Corp.
K070234	JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS	May 22, 2007	Substantially Equivalent	Jms North America Corp.
K040301	GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A	Nov 01, 2004	Unknown	Gambro Renal Products
K030268	NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS	Jul 30, 2003	Substantially Equivalent	C.R. Bard, Inc.
K030209	MAHURKAR OPLUS CATHETER, MODEL 13.5 FR	May 13, 2003	Substantially Equivalent	The Kendall Company
K022221	TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS	Jan 30, 2003	Unknown	Deltec, Inc.
K010778	NIAGARA SLIM-CATH	Apr 13, 2001	Substantially Equivalent	C.R. Bard, Inc.
K001958	KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH	Sep 25, 2000	Substantially Equivalent	Keystone Medical
K993933	14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO	Sep 14, 2000	Substantially Equivalent	Arrow Intl., Inc.
K991320	MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN	Nov 10, 1999	Substantially Equivalent	Medical Components, Inc.
K980438	11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT	Jun 10, 1999	Substantially Equivalent	Medical Components, Inc.
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	Jun 08, 1999	Substantially Equivalent	Medical Components, Inc.
K991431	14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT	May 26, 1999	Substantially Equivalent	Arrow Intl., Inc.
K984022	PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT	May 18, 1999	Substantially Equivalent	Arrow Intl., Inc.
K974236	MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB	Apr 15, 1999	Substantially Equivalent	Medical Components, Inc.
K965178	NIAGARA DUAL LUMEN CATHETER	Aug 19, 1997	Substantially Equivalent	Vas-Cath, Inc.
K963446	KENDALL DUAL LUMEN CATHETER	Mar 18, 1997	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K952660	BRAUN HEMODIALYSIS CATHETER	Sep 17, 1996	Substantially Equivalent	B.Braun Medical, Inc.
K955002	MAHURKAR 8 FR DUAL LEMEN CATHETER	Sep 13, 1996	Substantially Equivalent	Quinton, Inc.
K923691	TWIN SILICONE CATHETER	Sep 25, 1995	Unknown	Medical Components, Inc.
K896252	MODIFIED QUINTON SINGLE LUMEN CATHETER	Jan 29, 1990	Substantially Equivalent	Quinton, Inc.
K893188	QUINTON SINGLE LUMEN CATHETER	Jun 08, 1989	Substantially Equivalent	Quinton, Inc.
K880583	MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH	Feb 22, 1988	Substantially Equivalent	Quinton, Inc.
K871360	10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE	Apr 29, 1987	Substantially Equivalent	Quinton, Inc.