POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
FDA 510(k) clearance K083675 · decided 2009-03-19
Clearance details
- K-number
- K083675
- Device name
- POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-11
- Decision date
- 2009-03-19
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- NIE
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Salt Lake Ciy,, UT, 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 |
| 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 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web (P800002/S035) | C.R. Bard, Inc. | 2026-07-15 |
| Covera Vascular Covered Stent (P170042/S015) | C.R. Bard, Inc. | 2026-06-10 |
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |