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510(k) K250836

Device
14F Duo-Flow® Side X Side Double Lumen Catheter
Applicant
Medical Components, Inc.
510(k) number
K250836
Product code
MPB
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-12
Date received
2025-03-20
Regulation
876.5540
Classification name
Catheter, Hemodialysis, Non-Implanted
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Danielle McKinney
Address
1499 Delp Dr. Harleysville PA US 19438 19438

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MPB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation2020-12-24
K192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp)2020-04-23
K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLC2020-01-17
K163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.2017-04-04
K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated2017-01-06
K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.2016-01-05
K122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAYCook, Inc.2013-07-29
K120674MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETERCovidien2012-04-04
K110793AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITSAmeco Medical Industries2011-12-16
K102833DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETSFoshan Nanhai Bai HE Medical Technology Co., Ltd.2011-11-18
K100451GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132Gambro Renal Products, Inc.2010-12-21
K090102NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERSC.R. Bard, Inc.2009-02-12
K071145NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLENipro Medical Corporation2007-09-07
K063355D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOWNovosci Corp.2007-07-27
K070234JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETSJms North America Corp.2007-05-22