# K053345: Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Mar 17, 2006 after 105 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: 6 generations back to K001901 (2000). 8 ancestors in all.
43 later devices descend from it; 7 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033389: Powerpicc Catheters, Models 3175155, 3175135, C.R. Bard, Inc. (2004) Summary page 1.
- K051417: 6 FR FL Powerhohn and Powerline Catheter, C.R. Bard, Inc. (2005) Summary page 1.

## Most influential descendants
- K081904: Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray) (2008), 31 descendants of its own
- K091953: Pro-Picc (2009), 29 descendants of its own
- K072391: PFM Picc (2007), 9 descendants of its own
- K141151: CT Midline (2014), 8 descendants of its own
- K093309: Pro-Line CT (Basic Tray) Model MR28036101 (2009), 8 descendants of its own

## Recalls of this device
- Apr 11, 2008 · Not classified · Z-1910-2008: kit contains incorrect component

## Indications for use
The Medcomp PRO-LINE Tm CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PRO-LINE Tm CT Power Injectable CVC may not exceed 300 psi.

Source page: https://510kreport.com/device/K053345
Methodology: https://510kreport.com/methodology