# K172187: Inno-Hydrowire

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Innomed Medical Device Co., Ltd.
- Decided: Apr 11, 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
Longest line of descent: 1 generation back to K863138 (1986). 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)
- K863138: Terumo Radifocus Guide Wire, Terumo Medical Corp. (1986) Summary page 4.

## Indications for use
The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary use.

Source page: https://510kreport.com/device/K172187
Methodology: https://510kreport.com/methodology