FDA 510(k) Applications for Medical Device Product Code "NIE"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K143102 | Arrow International, Inc. (Subsidiary of Teleflex Inc.) | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | 07/24/2015 |
K133456 | C.R. BARD, INC. | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER | 09/24/2014 |
K141531 | C.R. BARD, INC. | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | 06/01/2015 |
K083675 | C.R. BARD, INC. | POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER | 03/19/2009 |
K102605 | COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER | 12/22/2010 |
K222170 | Health Line International Corporation | Power Acute Triple Lumen Hemodialysis Catheter | 01/13/2023 |
K033570 | MEDCOMP | MEDCOMP T-3 | 09/16/2004 |
K123292 | MEDCOMP | T3 | 06/11/2013 |
K181175 | Medical Components Inc. (Dba Medcomp) | 12F Tri-Flow Triple Lumen Catheter | 07/05/2018 |
K183219 | Medical Components Inc. (dba MedComp) | Trio-CT Triple Lumen Catheter | 06/14/2019 |
K020089 | THE KENDALL COMPANY | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | 04/10/2002 |