# K072625: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Dec 13, 2007 after 87 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: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 6 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081690: Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter (2008), 4 descendants of its own
- K132885: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set (2013), 2 descendants of its own
- K132334: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set (2013), 2 descendants of its own
- K100974: Spectrum Turbo-Ject Picc Set (2010), 2 descendants of its own
- K111244: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) (2011), 1 descendant of its own

## Recalls of this device
- Oct 4, 2010 · Not classified · Z-1186-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays 
- Oct 4, 2010 · Not classified · Z-1187-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays 
- Oct 4, 2010 · Not classified · Z-1188-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays 
- Oct 4, 2010 · Not classified · Z-1189-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays 
- Oct 4, 2010 · Not classified · Z-1181-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays 
- Oct 4, 2010 · Not classified · Z-1183-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays 
- Oct 4, 2010 · Not classified · Z-1182-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays 
- Oct 4, 2010 · Not classified · Z-1185-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays 
- Oct 4, 2010 · Not classified · Z-1184-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays 

## Indications for use
Turbo-Ject Peripherally Inserted Central Venous Catheters (PICC) are 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 PICC 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 PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rated indicated, as shown on the following table. Catheter Size | Maximum Flow Rate* | Injection Pressure Limit Setting 4 Fr Single Lumen | 4 ml/sec | 325 psi 4 Fr Double Lumen | 3mI/sec | 325 psi 5 Fr Single Lumen | 7 ml/sec | 325 psi 5 Fr Double Lumen | 5 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 cenripoise 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. Omnipaque 300® is a registered trademark of Amersham Health, New Jersey

Source page: https://510kreport.com/device/K072625
Methodology: https://510kreport.com/methodology