FDA 510(k) Applications for Medical Device Product Code "MPB"
(Catheter, Hemodialysis, Non-Implanted)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K110793 | AMECO MEDICAL INDUSTRIES | AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS | 12/16/2011 |
| K993933 | ARROW INTL., INC. | 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO | 09/14/2000 |
| K991431 | ARROW INTL., INC. | 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT | 05/26/1999 |
| K984022 | ARROW INTL., INC. | PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT | 05/18/1999 |
| K952660 | B. BRAUN MEDICAL, INC. | BRAUN HEMODIALYSIS CATHETER | 09/17/1996 |
| K153190 | C.R BARD INC. | Zenysis Short-Term Dialysis Catheter | 01/05/2016 |
| K163458 | C.R BARD. INC. | Zenysis Short-Term Dialysis Catheter | 04/04/2017 |
| K010778 | C.R. BARD, INC. | NIAGARA SLIM-CATH | 04/13/2001 |
| K030268 | C.R. BARD, INC. | NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS | 07/30/2003 |
| K090102 | C.R. BARD, INC. | NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS | 02/12/2009 |
| K161504 | COOK INCORPORATED | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray | 01/06/2017 |
| K122091 | COOK, INC. | COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY | 07/29/2013 |
| K120674 | COVIDIEN | MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER | 04/04/2012 |
| K192302 | Covidien, llc | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter | 01/17/2020 |
| K022221 | DELTEC, INC. | TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS | 01/30/2003 |
| K102833 | FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD | DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS | 11/18/2011 |
| K040301 | GAMBRO RENAL PRODUCTS | GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A | 11/01/2004 |
| K100451 | GAMBRO RENAL PRODUCTS, INC. | 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 | 12/21/2010 |
| K200426 | Health Line International Corporation | Acute Dual Lumen Hemodialysis Catheter | 12/24/2020 |
| K070234 | JMS NORTH AMERICA CORP. | JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS | 05/22/2007 |
| K963446 | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH | KENDALL DUAL LUMEN CATHETER | 03/18/1997 |
| K001958 | KEYSTONE MEDICAL | KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH | 09/25/2000 |
| K192807 | Medical Components Inc. (dba MedComp) | Duo-Flow Side x Side Double Lumen Catheter | 04/23/2020 |
| K980438 | MEDICAL COMPONENTS, INC. | 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT | 06/10/1999 |
| K991320 | MEDICAL COMPONENTS, INC. | MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN | 11/10/1999 |
| K974236 | MEDICAL COMPONENTS, INC. | MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB | 04/15/1999 |
| K983511 | MEDICAL COMPONENTS, INC. | SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH | 06/08/1999 |
| K071145 | NIPRO MEDICAL CORPORATION | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE | 09/07/2007 |
| K063355 | NOVOSCI CORP. | D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW | 07/27/2007 |
| K955002 | QUINTON, INC. | MAHURKAR 8 FR DUAL LEMEN CATHETER | 09/13/1996 |
| K030209 | THE KENDALL COMPANY | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR | 05/13/2003 |
| K965178 | VAS-CATH, INC. | NIAGARA DUAL LUMEN CATHETER | 08/19/1997 |
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