# K151985: PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 14, 2016 after 333 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051672: Powerpicc, Bard Access Systems, Inc. (2005) Summary page 5.
- K053501: Powerpicc, Bard Access Systems, Inc. (2006) Summary page 5.
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter, C.R. Bard, Inc. (2007) Summary page 5.
- K072230: Powerpicc Solo, C.R. Bard, Inc. (2007) Summary page 6.

## Most influential descendants
- K181904: 5 FR Dual Lumen Piper PICC (2018), 0 descendants of its own

## Indications for use
The PowerPICC®EtOH Catheter is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy including prolonged exposure to intraluminal solutions containing up to 70% ethanol, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy, use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. Catheter Size — Maximum Flow Rate 4F Single Lumen — 5 ml/sec 5F Dual Lumen — 5 ml/sec 5F Triple Lumen — 4 ml/sec The PowerPICC SOLO®2 EtOH Catheter is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy including prolonged exposure to intraluminal solutions containing up to 70% ethanol, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy, use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. Catheter Size — Maximum Flow Rate 4F Single Lumen — 5 ml/sec 5F Dual Lumen — 5 ml/sec 5F Triple Lumen — 4 ml/sec

Source page: https://510kreport.com/device/K151985
Methodology: https://510kreport.com/methodology