# K102159: Powerpicc SV Catheters

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 17, 2010 after 107 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 28 ancestors in all.
5 later devices descend from it; 2 cite it directly.
2 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034019: Poly Per-Q-Cath Picc Catheters, C.R. Bard, Inc. (2004) 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.
- K043502: 6 FR Poly Per-Q-Cath Triple Lumen Picc, C.R. Bard, Inc. (2005) Summary page 1.
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter, C.R. Bard, Inc. (2007) Summary page 1.
- K033389: Powerpicc Catheters, Models 3175155, 3175135, C.R. Bard, Inc. (2004) Summary page 1.
- K053501: Powerpicc, Bard Access Systems, Inc. (2006) Summary page 2.
- K093927: 6F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central Venous Catheter, C.R. Bard, Inc. (2010) Summary page 2.
- K072196: Angiodynamics, Inc Morpheus Picc and Procedure Kit, AngioDynamics, Inc. (2007) Summary page 2.

## Most influential descendants
- K162443: PowerPICC Provena Catheters (2016), 2 descendants of its own
- K162441: PowerPICC Provena Catheters with SOLO Valve Technology (2017), 1 descendant of its own
- K123617: 3F Pro-Picc (2013), 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
- K131687: 6F X 60CM Triple Pro-Line CT Basic IR Set (2013), 0 descendants of its own

## Recalls of this device
- May 21, 2026 · Class II · Z-2659-2026: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- Feb 26, 2020 · Class II · Z-2080-2020: The kits contain surgical gowns which were subject to a recall by the supplier.
- Feb 26, 2020 · Class II · Z-2081-2020: The kits contain surgical gowns which were subject to a recall by the supplier.

## Indications for use
The PowerPICC SV catheter is 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. Catheter Size Maximum Flow Rate 3 F Single Lumen 1 mL/sec 4 F Dual Lumen 2.5 mL/sec

Source page: https://510kreport.com/device/K102159
Methodology: https://510kreport.com/methodology