# K141818: Turbo-Ject Picc Sets

- Pathway: 510(k) (Special)
- Applicant: Cook Corporated
- Decided: Aug 5, 2014 after 29 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: 6 generations back to K862056 (1986). 14 ancestors in all.
No later device cites it as a predicate yet.
2 of 15 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 4.
- K111244: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc), Cook, Inc. (2011) Summary page 4.
- K132334: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set, Cook, Inc. (2013) Summary page 4.
- K132885: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set, Cook Incorporated (2013) Summary page 4.

## Indications for use
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 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 rate indicated.

Source page: https://510kreport.com/device/K141818
Methodology: https://510kreport.com/methodology