# K081690: Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Jul 14, 2008 after 27 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K862056 (1986). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021557: Spectrum Silicone Catheter, Cook, Inc. (2003) Summary page 1.
- K072625: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc), Cook, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K141818: Turbo-Ject Picc Sets (2014), 0 descendants of its own
- K133634: Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter Set (2013), 0 descendants of its own

## Indications for use
The Spectrum Turbo-JeCT PICC 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 catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum 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 Spectrum Turbo-JeCT PICC 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 4 Fr Single Lumen | 4 ml/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 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. Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.

Source page: https://510kreport.com/device/K081690
Methodology: https://510kreport.com/methodology