# K120298: CPS Excel Mediguide Enabled Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
- Decided: May 8, 2012 after 98 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: 12 generations back to K926514 (1993). 74 ancestors in all.
8 later devices descend from it; 2 cite it directly.
6 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073082: CPS Courier Guidewire, Brivant, Ltd. (2008) Summary page 1.
- K091781: Guided Medical Positioning System (GMPS), Mediguide, Ltd. (2009) Summary page 1.

## Most influential descendants
- K190106: Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle (2019), 6 descendants of its own
- K230309: Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) (2023), 5 descendants of its own
- K242133: Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (2024), 3 descendants of its own
- K241243: Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) (2024), 3 descendants of its own
- K243842: Intra-Operative Positioning System (IOPS®) (2025), 2 descendants of its own

## Indications for use
The St. Jude Medical CPS Excel™ MediGuide Enabled™Guidewire is intended for use with the MediGuide™ System to enable real-time tip positioning and navigation within the coronary and peripheral vasculature (such as to facilitate left heart lead implantation). The MediGuide system is intended for use as an adjunct to fluoroscopy.

Source page: https://510kreport.com/device/K120298
Methodology: https://510kreport.com/methodology