# K080637: Powerasset Radiofrequency Guidwire, Model Various

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Aug 12, 2008 after 159 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 K890505 (1989). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051670: RF Tunneler Wire, Baylis Medical Co., Inc. (2006) Summary page 1.
- K042854: Stereotaxis Endovascular Guide Wire, Stereotaxis, Inc. (2005) Summary page 1.
- K043457: Modification to Endovascular Guide Wire, Stereotaxis, Inc. (2005) Summary page 1.

## Indications for use
The PowerAssertTM Radiofrequency Guidewire (PARG) is intended for use with a Stereotaxis Niobe Magnetic Navigation System for the recanalization of occluded peripheral vessels.

Source page: https://510kreport.com/device/K080637
Methodology: https://510kreport.com/methodology