Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
FDA 510(k) clearance K143102 · decided 2015-07-24
Clearance details
- K-number
- K143102
- Device name
- Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Decision
- Unknown
- Date received
- 2014-10-29
- Decision date
- 2015-07-24
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- NIE
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Reading, 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 |
| Trio-CT Triple Lumen Catheter (K183219) | Medical Components, Inc. (dba MedComp) | 2019-06-14 |
| 12F Tri-Flow Triple Lumen Catheter (K181175) | Medical Components, Inc. (dba MedComp) | 2018-07-05 |
| 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
| Record | Firm | Date |
|---|---|---|
| Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK recall (Z-2374-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |