Atlas FDA

NIE

12 FDA 510(k) clearances · Product code

206 daysmedian time to decision
316 days90th percentile
12clearances measured

FDA profile

Official device name
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
FDA definition
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Adverse events (MAUDE)
2021: 61 · 2022: 119 · 2023: 103 · 2024: 125 · 2025: 74 · 2026: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Trio-CT­® Triple Lumen Catheter w/ Curved Extensions (K232945)Medical Components, Inc. (dba MedComp)2023-11-16
Power Acute Triple Lumen Hemodialysis Catheter (K222170)Health Line International Corporation2023-01-13
Trio-CT Triple Lumen Catheter (K183219)Medical Components, Inc. (dba MedComp)2019-06-14
12F Tri-Flow Triple Lumen Catheter (K181175)Medical Components, Inc. (dba MedComp)2018-07-05
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions (K143102)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2015-07-24
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER (K141531)C.R. Bard, Inc.2015-06-01
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER (K133456)C.R. Bard, Inc.2014-09-24
T3 (K123292)Medcomp2013-06-11
MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER (K102605)Covidien, LLC, Formerly Registered AS Tyco Healthca2010-12-22
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER (K083675)C.R. Bard, Inc.2009-03-19
MEDCOMP T-3 (K033570)Medcomp2004-09-16
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR (K020089)The Kendall Company2002-04-10

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