# K162443: PowerPICC Provena Catheters

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 25, 2016 after 55 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: 9 generations back to K001901 (2000). 29 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102159: Powerpicc SV Catheters, C.R. Bard, Inc. (2010) Summary page 4.

## Most influential descendants
- K162441: PowerPICC Provena Catheters with SOLO Valve Technology (2017), 1 descendant of its own
- K180548: 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology (2018), 0 descendants of its own

## Recalls of this device
- Dec 28, 2017 · Class II · Z-0536-2018: Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.

## Indications for use
The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Source page: https://510kreport.com/device/K162443
Methodology: https://510kreport.com/methodology