# 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

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc (Bard Has Joined Bd)
- Decided: Apr 26, 2018 after 56 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: 11 generations back to K001901 (2000). 31 ancestors in all.
No later device cites it as a predicate yet.
2 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162443: PowerPICC Provena Catheters, C.R. Bard, Inc. (2016) Summary page 5.
- K162441: PowerPICC Provena Catheters with SOLO Valve Technology, C.R. Bard, Inc. (2017) Summary page 5.

## Recalls of this device
- May 21, 2026 · Class II · Z-2664-2026: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

## Indications for use
The PowerPICC Provena Catheters with SOLO2 Valve Technology 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. 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/K180548
Methodology: https://510kreport.com/methodology