# K111263: Cxi Triforce

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 25, 2011 after 82 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: 6 generations back to K001992 (2000). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072724: Cxi Support Catheter, Cook, Inc. (2007) Summary page 1.
- K082519: Finecross MG Coronary Micro-Guide Catheter, Terumo Medical Corp. (2008) Summary page 1.
- K102008: Glidesheath, Terumo Medical Corp. (2010) Summary page 1.

## Most influential descendants
- K170931: CXI TriForce Peripheral Crossing Set (2017), 0 descendants of its own

## Indications for use
The CXI TriForce Peripheral Crossing Set 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/K111263
Methodology: https://510kreport.com/methodology