# K220934: RADIFOCUS Torque Device

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.
- Decided: Jun 29, 2022 after 90 days
- Product code: MOF (Guide, Wire, Catheter, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910969 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910969: Torque Device for a Guide Wire, Terumo Corp. (1991) Summary page 5.

## Indications for use
RADIFOCUS Torque Device is intended to facilitate guidewire manipulation during interventional procedures.

Source page: https://510kreport.com/device/K220934
Methodology: https://510kreport.com/methodology