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)
Top companies in NIE
| Company | 510(k)s | Recalls |
|---|---|---|
| COVIDIEN LLC | 0 | 27 |
| Mozarc Medical US LLC | 0 | 6 |
| C.R. Bard, Inc. | 3 | 0 |
| Medical Components, Inc. (dba MedComp) | 3 | 0 |
| ARROW INTERNATIONAL, LLC | 0 | 2 |
| Bard Access Systems, Inc. | 0 | 2 |
| Medcomp | 2 | 0 |
| Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 1 | 0 |
| Becton Dickinson & Company | 0 | 1 |
| Covidien, LLC, Formerly Registered AS Tyco Healthca | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2023 | K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions Medical Components, Inc. (dba MedComp) | NIE |
| Jan 13, 2023 | K222170 | Power Acute Triple Lumen Hemodialysis Catheter Health Line International Corporation | NIE |
| Jun 14, 2019 | K183219 | Trio-CT Triple Lumen Catheter Medical Components, Inc. (dba MedComp) | NIE |
| Jul 5, 2018 | K181175 | 12F Tri-Flow Triple Lumen Catheter Medical Components, Inc. (dba MedComp) | NIE |
| Jul 24, 2015 | K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | NIE |
| Jun 1, 2015 | K141531 | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER C.R. Bard, Inc. | NIE |
| Sep 24, 2014 | K133456 | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER C.R. Bard, Inc. | NIE |
| Jun 11, 2013 | K123292 | T3 Medcomp | NIE |
| Dec 22, 2010 | K102605 | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER Covidien, LLC, Formerly Registered AS Tyco Healthca | NIE |
| Mar 19, 2009 | K083675 | POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER C.R. Bard, Inc. | NIE |
| Sep 16, 2004 | K033570 | MEDCOMP T-3 Medcomp | NIE |
| Apr 10, 2002 | K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR The Kendall Company | NIE |
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