510(k) K183219
- Device
- Trio-CT Triple Lumen Catheter
- Applicant
- Medical Components Inc. (dba MedComp)
- 510(k) number
- K183219
- Product code
- NIE
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 2019-06-14
- Date received
- 2018-11-20
- Regulation
- 876.5540
- Classification name
- Catheter, Hemodialysis, Triple Lumen, Non-implanted
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Courtney Nix
- Address
- 1499 Delp Dr. Harleysville PA US 19438 19438
FDA Registration Numbers#
- 1000563940
- 3009888344
- 3007544634
- 3009211636
- 3010882065
- 3030574705
- 2518902
- 1721676
- 9680794
- 9617592
- 9610849
- 3006260740
- 2030624
- 2011171
- 3006082230
- 1319639
- 1018233
- 3015859709
- 1282497
- 3003915875
Source Documents#
Other 510(k) Records For Product Code NIE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) | 2023-11-16 |
| K222170 | Power Acute Triple Lumen Hemodialysis Catheter | Health Line International Corporation | 2023-01-13 |
| K181175 | 12F Tri-Flow Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2018-07-05 |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015-07-24 |
| K141531 | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | C.R. Bard, Inc. | 2015-06-01 |
| K133456 | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER | C.R. Bard, Inc. | 2014-09-24 |
| K123292 | T3 | Medcomp | 2013-06-11 |
| K102605 | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010-12-22 |
| K083675 | POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER | C.R. Bard, Inc. | 2009-03-19 |
| K033570 | MEDCOMP T-3 | Medcomp | 2004-09-16 |
| K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | The Kendall Company | 2002-04-10 |
Legacy Summary#
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FDA Review#
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