# K182553: Inno-Pathwire

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Innomed Medical Device Co., Ltd.
- Decided: Mar 11, 2019 after 175 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: 8 generations back to K913353 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152709: HI-Torque Balance, Abbott Vascular (2015) Summary page 4.

## Indications for use
The Inno-Pathwire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Source page: https://510kreport.com/device/K182553
Methodology: https://510kreport.com/methodology