# K034019: Poly Per-Q-Cath Picc Catheters

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 21, 2004 after 28 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.
239 later devices descend from it; 6 cite it directly.
16 of 243 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 1.

## Most influential descendants
- K050931: 6 FR DL Powerpicc Catheter (2005), 199 descendants of its own
- K051672: Powerpicc (2005), 178 descendants of its own
- K043502: 6 FR Poly Per-Q-Cath Triple Lumen Picc (2005), 133 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 Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.

Source page: https://510kreport.com/device/K034019
Methodology: https://510kreport.com/methodology