# K133634: Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter Set

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Dec 23, 2013 after 27 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: 4 generations back to K862056 (1986). 12 ancestors in all.
No later device cites it as a predicate yet.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081690: Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter, Cook, Inc. (2008) Summary page 1.
- K072625: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc), Cook, Inc. (2007) Summary page 1.
- K132334: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set, Cook, Inc. (2013) Summary page 1.
- K132885: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set, Cook Incorporated (2013) Summary page 1.

## Indications for use
Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended 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.

Source page: https://510kreport.com/device/K133634
Methodology: https://510kreport.com/methodology