# K080364: Findrwirz Guide Wire System

- Pathway: 510(k) (Traditional)
- Applicant: Sentreheart, Inc.
- Decided: Aug 11, 2008 after 182 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941895 (1994). 22 ancestors in all.
No later device cites it as a predicate yet.
2 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914138: Ontrac, Lake Region Mfg., Inc. (1991) Summary page 2.
- K042854: Stereotaxis Endovascular Guide Wire, Stereotaxis, Inc. (2005) Summary page 2.
- K071457: Modification to Radius Snare, Radius Medical Technologies, Inc. (2007) Summary page 2.

## Recalls of this device
- Sep 29, 2016 · Class I · Z-0328-2017: A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed 

## Indications for use
The FindrWIRZ System is intended for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. A FindrWIRZ may also be used to manipulate and or reposition another FindrWIRZ. The FindrWIRZ System is not intended for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K080364
Methodology: https://510kreport.com/methodology