# K992051: Radifocus Optitorque

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Aug 10, 1999 after 53 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: 2 generations back to K921310 (1992). 5 ancestors in all.
32 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863137: Terumo Radifocus Angiographic Catheter, Terumo Medical Corp. (1986) Summary page 1.
- K915414: Terumo Angiogtaphic Catheter, Terumo Medical Corp. (1992) Summary page 1.
- K960975: 1-4F Infiniti Angiographic Catheter, Cordis Corp. (1996) Summary page 1.

## Most influential descendants
- K082561: Spectranetics Quick-Cross Extreme Support Catheters (2008), 18 descendants of its own
- K092396: Spectranetics Quick Cross Extreme Support Catheters (2009), 13 descendants of its own
- K082736: Radifocus Optitorque Angiographic Catheter (2008), 9 descendants of its own
- K110540: Terumo Support Catheter (2011), 6 descendants of its own
- K150232: Radifocus Optitorque Angiographic Catheter (2015), 4 descendants of its own

## Indications for use
The RADIFOCUS® Optitorque Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system.

Source page: https://510kreport.com/device/K992051
Methodology: https://510kreport.com/methodology