# K111244: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Jun 14, 2011 after 42 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: 5 generations back to K862056 (1986). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072625: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc), Cook, Inc. (2007) Summary page 2.
- K100974: Spectrum Turbo-Ject Picc Set, Cook Incorporated (2010) Summary page 2.

## Most influential descendants
- K141818: Turbo-Ject Picc Sets (2014), 0 descendants of its own

## Indications for use
The Turbo-Ject® P1CC is indicated for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject® P1CC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Turbo-Ject® P1CC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated. Catheter Size | Maximum Flow Rate* | Injection Pressure Limit Setting 3.0 Fr Single Lumen | 2 mL/sec | 325 psi 4.0 Fr Single Lumen | 4 mL/sec | 325 psi 4.0 Fr Double Lumen | 3 mL/sec | 325 psi 5.0 Fr Single Lumen | 7 mL/sec | 325 psi 5.0 Fr Double Lumen | 5 mL/sec | 325 psi 6.0 Fr Triple Lumen** | 7 mL/sec | 325 psi *Flow rates achieved using room temperature Omnipaque 300® contrast and verified using a Medrad Stellant® CT injector system. Omnipaque 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosity of the contrast medium used will result in a change in achievable flow rates. **Lumen #1 only. Omnipaque 300® is a registered trademark of GE Healthcare.

Source page: https://510kreport.com/device/K111244
Methodology: https://510kreport.com/methodology