# K033389: Powerpicc Catheters, Models 3175155, 3175135

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 19, 2004 after 148 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001901 (2000). 3 ancestors in all.
208 later devices descend from it; 11 cite it directly.
15 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031129: Poly Per-Q-Cath Picc Catheters; Poly Radpicc, C.R. Bard, Inc. (2003) Summary page 4.

## Most influential descendants
- K050931: 6 FR DL Powerpicc Catheter (2005), 199 descendants of its own
- K051672: Powerpicc (2005), 178 descendants of its own
- K050185: Powerhohn and Powerline Catheters (2005), 127 descendants of its own
- K051417: 6 FR FL Powerhohn and Powerline Catheter (2005), 126 descendants of its own
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line (2005), 119 descendants of its own

## Recalls of this device
- Aug 8, 2014 · Class II · Z-1271-2015: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of 

## Indications for use
The PowerPICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.

Source page: https://510kreport.com/device/K033389
Methodology: https://510kreport.com/methodology