ClearanceBrief
Panels › Gastroenterology, Urology › Product code NIE · Class 2

Catheter, Hemodialysis, Triple Lumen, Non-Implanted

Regulation 876.5540

0510(k)s in 12 months (12 all time)
9recalls in 12 months (38 all time)
38recalls that name a 510(k)
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Top companies in NIE

Company510(k)sRecalls
COVIDIEN LLC027
Mozarc Medical US LLC06
C.R. Bard, Inc.30
Medical Components, Inc. (dba MedComp)30
ARROW INTERNATIONAL, LLC02
Bard Access Systems, Inc.02
Medcomp20
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)10
Becton Dickinson & Company01
Covidien, LLC, Formerly Registered AS Tyco Healthca10
DateFirm and productCodeLinked 510(k)
Jul 2, 2026Bard Access Systems, Inc.
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Tr
Open, Classified		 NIEK141531
Jul 2, 2026Bard Access Systems, Inc.
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Co
Open, Classified		 NIEK133456
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT:
Open, Classified		 NIEK143102
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Open, Classified		 NIEK192302
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Open, Classified		 NIEK192302
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Open, Classified		 NIEK192302
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Open, Classified		 NIEK192302
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
Open, Classified		 NIEK192302
Nov 4, 2025Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Open, Classified		 NIEK192302
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
Open, Classified		 NIEK020089
K102605
Aug 11, 2023Covidien LP
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
Open, Classified		 NIEK020089
K102605
Jan 12, 2023Covidien LP
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888
Open, Classified		 NIEK030209
Sep 16, 2019Becton Dickinson & Company
13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection
Terminated		 NIEK133456
Apr 29, 2019COVIDIEN LLC
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8
Terminated		 NIEK020089
K030209 +3
Dec 22, 2017Arrow International Inc
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Terminated		 NIEK143102

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