# K150232: Radifocus Optitorque Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ashitaka Factory of Terumo Corp.
- Decided: Oct 19, 2015 after 259 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). 7 ancestors in all.
4 later devices descend from it; 1 cites 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 7.

## Most influential descendants
- 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
- K233853: LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub (2024), 1 descendant of its own
- K252645: LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub (2025), 0 descendants of its own

## Indications for use
The Radifocus Optitorque Angiographic Catheter is indicated for use in 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/K150232
Methodology: https://510kreport.com/methodology