# K113335: Heartrail Iii Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Terumo Corporation
- Decided: Jul 16, 2012 after 245 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K921310 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092372: Heartrail Iii Guiding Catheter, Terumo Corp. (2009) Summary page 2.

## Indications for use
The HeartrailTM III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.

Source page: https://510kreport.com/device/K113335
Methodology: https://510kreport.com/methodology