# K191502: Heraeus Peripheral Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Medical Components, LLC
- Decided: Nov 26, 2019 after 173 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.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122573: HI-Torque Command Guide Wire Family, Abbott Vascular, Inc. (2012) Summary page 4.

## Indications for use
Intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in peripheral arteries including but not limited to femoral, popliteal, and infra-popliteal arteries. This guide wire may also be used with compatible interventional devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

Source page: https://510kreport.com/device/K191502
Methodology: https://510kreport.com/methodology