Trio-CT Triple Lumen Catheter
FDA 510(k) clearance K183219 · decided 2019-06-14
Clearance details
- K-number
- K183219
- Device name
- Trio-CT Triple Lumen Catheter
- Applicant
- Medical Components, Inc. (dba MedComp)
- Decision
- Unknown
- Date received
- 2018-11-20
- Decision date
- 2019-06-14
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- NIE
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 Corporation | 2023-01-13 |
| 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) | Medcomp | 2013-06-11 |
| MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER (K102605) | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010-12-22 |
| POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER (K083675) | C.R. Bard, Inc. | 2009-03-19 |
| MEDCOMP T-3 (K033570) | Medcomp | 2004-09-16 |
| MAHURKAR TRIPLE LUMEN CATHETER, 12 FR (K020089) | The Kendall Company | 2002-04-10 |
Recalls involving this device
No recalls on record reference this clearance.