# K082736: Radifocus Optitorque Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Sep 24, 2008 after 6 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: 3 generations back to K921310 (1992). 6 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992051: Radifocus Optitorque, Terumo Medical Corp. (1999) Summary page 1.

## Most influential descendants
- K150232: Radifocus Optitorque Angiographic Catheter (2015), 4 descendants of its own
- K201081: AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter (2020), 3 descendants of its own
- K223918: AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub (2023), 2 descendants of its own
- K092372: Heartrail Iii Guiding Catheter (2009), 2 descendants of its own
- K233853: LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub (2024), 1 descendant of its own

## Indications for use
The Radifocus Optitorque Angiographic 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 femoral, radial, and brachial artery.

Source page: https://510kreport.com/device/K082736
Methodology: https://510kreport.com/methodology