Panels › Gastroenterology, Urology › Product code MPB · Class 2
Catheter, Hemodialysis, Non-Implanted
Regulation 876.5540
0510(k)s in 12 months (38 all time)
4recalls in 12 months (24 all time)
23recalls that name a 510(k)
Top companies in MPB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 12, 2025 | K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter Medical Components, Inc. | MPB |
| Dec 24, 2020 | K200426 | Acute Dual Lumen Hemodialysis Catheter Health Line International Corporation | MPB |
| Apr 23, 2020 | K192807 | Duo-Flow Side x Side Double Lumen Catheter Medical Components, Inc. (dba MedComp) | MPB |
| Jan 17, 2020 | K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Covidien, LLC | MPB |
| Apr 4, 2017 | K163458 | Zenysis Short-Term Dialysis Catheter C.R. Bard, Inc. | MPB |
| Jan 6, 2017 | K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Incorporated | MPB |
| Jan 5, 2016 | K153190 | Zenysis Short-Term Dialysis Catheter C.R. Bard, Inc. | MPB |
| Jul 29, 2013 | K122091 | COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY Cook, Inc. | MPB |
| Apr 4, 2012 | K120674 | MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER Covidien | MPB |
| Dec 16, 2011 | K110793 | AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS Ameco Medical Industries | MPB |
| Nov 18, 2011 | K102833 | DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS Foshan Nanhai Bai HE Medical Technology Co., Ltd., CN | MPB |
| 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 Gambro Renal Products, Inc. | MPB |
| Feb 12, 2009 | K090102 | NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS C.R. Bard, Inc. | MPB |
| Sep 7, 2007 | K071145 | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE Nipro Medical Corporation | MPB |
| Jul 27, 2007 | K063355 | D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW Novosci Corp. | MPB |
| May 22, 2007 | K070234 | JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS Jms North America Corp. | MPB |
| Nov 1, 2004 | K040301 | GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A Gambro Renal Products | MPB |
| Jul 30, 2003 | K030268 | NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS C.R. Bard, Inc. | MPB |
| May 13, 2003 | K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR The Kendall Company | MPB |
| Jan 30, 2003 | K022221 | TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS Deltec, Inc. | MPB |
| Apr 13, 2001 | K010778 | NIAGARA SLIM-CATH C.R. Bard, Inc. | MPB |
| Sep 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 Keystone Medical | MPB |
| Sep 14, 2000 | K993933 | 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO Arrow Intl., Inc. | MPB |
| Nov 10, 1999 | K991320 | MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN Medical Components, Inc. | MPB |
| 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. | MPB |
| 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 Medical Components, Inc. | MPB |
| May 26, 1999 | K991431 | 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT Arrow Intl., Inc. | MPB |
| May 18, 1999 | K984022 | PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT Arrow Intl., Inc. | MPB |
| Apr 15, 1999 | K974236 | MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB Medical Components, Inc. | MPB |
| Aug 19, 1997 | K965178 | NIAGARA DUAL LUMEN CATHETER Vas-Cath, Inc., CA | MPB |
| Mar 18, 1997 | K963446 | KENDALL DUAL LUMEN CATHETER Kendall Healthcare Products Co. Div.Of Tyco Health | MPB |
| Sep 17, 1996 | K952660 | BRAUN HEMODIALYSIS CATHETER B.Braun Medical, Inc. | MPB |
| Sep 13, 1996 | K955002 | MAHURKAR 8 FR DUAL LEMEN CATHETER Quinton, Inc. | MPB |
| Sep 25, 1995 | K923691 | TWIN SILICONE CATHETER Medical Components, Inc. | MPB |
| Jan 29, 1990 | K896252 | MODIFIED QUINTON SINGLE LUMEN CATHETER Quinton, Inc. | MPB |
| Jun 8, 1989 | K893188 | QUINTON SINGLE LUMEN CATHETER Quinton, Inc. | MPB |
| Feb 22, 1988 | K880583 | MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH Quinton, Inc. | MPB |
| Apr 29, 1987 | K871360 | 10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE Quinton, Inc. | MPB |
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