# K051373: Cronus Guidewire, Model 001-001470-1

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Dec 9, 2005 after 197 days
- Product code: NDQ (System, Catheter Or Guidewire, Steerable (Magnetic))
- Device class: 2
- Regulation: 21 CFR 870.1290
- Recalls of this device: none
- 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.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013484: Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath, Stereotaxis, Inc. (2002) Summary page 5.
- K983831: VECTORVISION2, Brainlab AG (1999) Summary page 5.
- K042854: Stereotaxis Endovascular Guide Wire, Stereotaxis, Inc. (2005) Summary page 5.
- K971254: Transend EX Platinum Guidewire, Boston Scientific Corp (1997) Summary page 5.

## Indications for use
The Stereotaxis Cronus™ Endovascular Guidewire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the neurovasculature, coronary and peripheral vasculature during PTCA or other intravascular interventional procedures. The Stereotaxis Cronus™ Endovascular Guidewire is not intended for use without a Stereotaxis Magnetic Navigation System [MNS]. Rotational atherectomy devices and any ferromagnetic interventional devices are contraindicated for use with the Stereotaxis Endovascular Guidewire. The TMNS is intended to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary, peripheral, and neurovasculature by orienting the device tip in a desired direction.

Source page: https://510kreport.com/device/K051373
Methodology: https://510kreport.com/methodology