# K083675: Power-Trialysis Triple Lumen Acute Dialysis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 19, 2009 after 98 days
- Product code: NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 23 ancestors in all.
12 later devices descend from it; 4 cite it directly.
7 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010778: Niagara Slim-Cath, C.R. Bard, Inc. (2001) Summary page 1.
- K053501: Powerpicc, Bard Access Systems, Inc. (2006) Summary page 1.
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line, C.R. Bard, Inc. (2005) Summary page 1.
- K020089: Mahurkar Triple Lumen Catheter, 12 FR, The Kendall Company (2002) Summary page 2.

## Most influential descendants
- K102605: Mahurkar Triple Lumen Dialysis Catheter (2010), 7 descendants of its own
- K133456: Power-Trialysis Short-Term Dialysis Catheter (2014), 2 descendants of its own
- K123292: T3 (2013), 2 descendants of its own
- K183219: Trio-CT Triple Lumen Catheter (2019), 1 descendant of its own
- K141531: Power-Trialysis Slim-Cath Short-Term Dialysis Catheter (2015), 1 descendant of its own

## Indications for use
The Power-TrialysisTM Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media.

Source page: https://510kreport.com/device/K083675
Methodology: https://510kreport.com/methodology