# K180830: Reuter Tip Deflecting Wire Guide

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Dec 20, 2018 after 265 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Reuter Tip Deflecting Wire Guide: named in the summary without a submission number

## Indications for use
Disposable Reuter Tip Deflecting Wire Guides are intended for use in curving or deflecting catheter tips for pulmonary angiography, selective angiography, translumbar aortography, bronchography, repositioning of central venous catheter tips and other vascular and non-vascular applications. Reuter Tip Deflecting Wire Guides are intended for use with the Reuter Tip Deflecting Handle assembly for curving or deflecting catheter tips for pulmonary angiography, selective angiography, translumbar aortography, bronchography, repositioning of central venous catheter tips and other vascular and non-vascular applications.

Source page: https://510kreport.com/device/K180830
Methodology: https://510kreport.com/methodology