# K092372: Heartrail Iii Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: Sep 11, 2009 after 37 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: 4 generations back to K921310 (1992). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082736: Radifocus Optitorque Angiographic Catheter, Terumo Medical Corp. (2008) Summary page 3.
- K981788: Scimed 6 French Wiseguide Guide Catheter, Scimed Life Systems, Inc. (1998) Summary page 3.

## Most influential descendants
- K132556: Sheathless Eaucath Coronary Guide Catheter (2013), 0 descendants of its own
- K113335: Heartrail Iii Guiding Catheter (2012), 0 descendants of its own

## 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/K092372
Methodology: https://510kreport.com/methodology