# K170931: CXI TriForce Peripheral Crossing Set

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Nov 13, 2017 after 229 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001992 (2000). 24 ancestors in all.
No later device cites it as a predicate yet.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111263: Cxi Triforce, Cook Incorporated (2011) Summary page 4.

## Indications for use
The CXI TriForce is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral intervention. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

Source page: https://510kreport.com/device/K170931
Methodology: https://510kreport.com/methodology