Atlas FDA

MPB

38 FDA 510(k) clearances · Product code

205 daysmedian time to decision
463 days90th percentile
38clearances measured

FDA profile

Official device name
Catheter, Hemodialysis, Non-Implanted
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 192 · 2022: 166 · 2023: 203 · 2024: 181 · 2025: 191 · 2026: 84
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
14F Duo-Flow® Side X Side Double Lumen Catheter (K250836)Medical Components, Inc.2025-08-12
Acute Dual Lumen Hemodialysis Catheter (K200426)Health Line International Corporation2020-12-24
Duo-Flow Side x Side Double Lumen Catheter (K192807)Medical Components, Inc. (dba MedComp)2020-04-23
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter (K192302)Covidien, LLC2020-01-17
Zenysis Short-Term Dialysis Catheter (K163458)C.R. Bard, Inc.2017-04-04
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (K161504)Cook Incorporated2017-01-06
Zenysis Short-Term Dialysis Catheter (K153190)C.R. Bard, Inc.2016-01-05
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY (K122091)Cook, Inc.2013-07-29
MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (K120674)Covidien2012-04-04
AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS (K110793)Ameco Medical Industries2011-12-16
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS (K102833)Foshan Nanhai Bai HE Medical Technology Co., Ltd.2011-11-18
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 (K100451)Gambro Renal Products, Inc.2010-12-21
NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS (K090102)C.R. Bard, Inc.2009-02-12
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE (K071145)Nipro Medical Corporation2007-09-07
D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW (K063355)Novosci Corp.2007-07-27
JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS (K070234)Jms North America Corp.2007-05-22
GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A (K040301)Gambro Renal Products2004-11-01
NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS (K030268)C.R. Bard, Inc.2003-07-30
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR (K030209)The Kendall Company2003-05-13
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS (K022221)Deltec, Inc.2003-01-30
NIAGARA SLIM-CATH (K010778)C.R. Bard, Inc.2001-04-13
KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH (K001958)Keystone Medical2000-09-25
14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO (K993933)Arrow Intl., Inc.2000-09-14
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN (K991320)Medical Components, Inc.1999-11-10
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT (K980438)Medical Components, Inc.1999-06-10
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH (K983511)Medical Components, Inc.1999-06-08
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT (K991431)Arrow Intl., Inc.1999-05-26
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT (K984022)Arrow Intl., Inc.1999-05-18
MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB (K974236)Medical Components, Inc.1999-04-15
NIAGARA DUAL LUMEN CATHETER (K965178)Vas-Cath, Inc.1997-08-19
KENDALL DUAL LUMEN CATHETER (K963446)Kendall Healthcare Products Co. Div.Of Tyco Health1997-03-18
BRAUN HEMODIALYSIS CATHETER (K952660)B.Braun Medical, Inc.1996-09-17
MAHURKAR 8 FR DUAL LEMEN CATHETER (K955002)Quinton, Inc.1996-09-13
TWIN SILICONE CATHETER (K923691)Medical Components, Inc.1995-09-25
MODIFIED QUINTON SINGLE LUMEN CATHETER (K896252)Quinton, Inc.1990-01-29
QUINTON SINGLE LUMEN CATHETER (K893188)Quinton, Inc.1989-06-08
MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH (K880583)Quinton, Inc.1988-02-22
10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE (K871360)Quinton, Inc.1987-04-29

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Every clearance here is in the API, with alerts when new ones post.