# K112674: Navis Torquer

- Pathway: 510(k) (Traditional)
- Applicant: Navis Medical,Inc
- Decided: Jul 6, 2012 after 296 days
- Product code: DQX (Wire, Guide, Catheter)
- 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: 4 generations back to K854261 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 1.
- K072552: Merit Medical Systems, Inc., Guide Wire Torque Device, Merit Medical Systems, Inc. (2007) Summary page 1.

## Indications for use
The Navis Torquer is intended to facilitate guide wire manipulation during interventional procedures.

Source page: https://510kreport.com/device/K112674
Methodology: https://510kreport.com/methodology