FDA.reportPublic FDA data

510(k) K222170

Device
Power Acute Triple Lumen Hemodialysis Catheter
Applicant
Health Line International Corporation
510(k) number
K222170
Product code
NIE
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-13
Date received
2022-07-21
Regulation
876.5540
Classification name
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Aaron G Faulkner
Address
260 N Ace Yeager Ct. Unit D Slat Lake City UT US 84116 84116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NIE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)2023-11-16
K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)2019-06-14
K18117512F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp)2018-07-05
K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.)2015-07-24
K141531POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETERC.R. Bard, Inc.2015-06-01
K133456POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETERC.R. Bard, Inc.2014-09-24
K123292T3Medcomp2013-06-11
K102605MAHURKAR TRIPLE LUMEN DIALYSIS CATHETERCovidien, LLC, Formerly Registered AS Tyco Healthca2010-12-22
K083675POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETERC.R. Bard, Inc.2009-03-19
K033570MEDCOMP T-3Medcomp2004-09-16
K020089MAHURKAR TRIPLE LUMEN CATHETER, 12 FRThe Kendall Company2002-04-10