FDA Product Code
FDA Product Code NIE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5540
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) | 2023-11-16 | Traditional | PDF ↗ |
| K222170 | Power Acute Triple Lumen Hemodialysis Catheter | Health Line International Corporation | 2023-01-13 | Traditional | PDF ↗ |
| K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2019-06-14 | Traditional | PDF ↗ |
| K181175 | 12F Tri-Flow Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2018-07-05 | Traditional | PDF ↗ |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015-07-24 | Traditional | PDF ↗ |
| K141531 | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | C.R. Bard, Inc. | 2015-06-01 | Traditional | PDF ↗ |
| K133456 | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER | C.R. Bard, Inc. | 2014-09-24 | Traditional | PDF ↗ |
| K123292 | T3 | Medcomp | 2013-06-11 | Traditional | PDF ↗ |
| K102605 | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010-12-22 | Traditional | PDF ↗ |
| K083675 | POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER | C.R. Bard, Inc. | 2009-03-19 | Traditional | PDF ↗ |
| K033570 | MEDCOMP T-3 | Medcomp | 2004-09-16 | Traditional | PDF ↗ |
| K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | The Kendall Company | 2002-04-10 | Traditional | PDF ↗ |
Product code NIE · Class II · Gastroenterology, Urology. Data: openFDA.