# K091780: Guided Measurement Catheter (GMC)

- Pathway: 510(k) (Traditional)
- Applicant: Mediguide, Ltd.
- Decided: Oct 16, 2009 after 121 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K934139 (1995). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051337: Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001, Volcano Corporation (2005) Summary page 2.
- K042685: Metricath System, Angiometrx, Inc. (2004) Summary page 2.
- K080425: CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02, Biosense Webster, Inc. (2008) Summary page 2.

## Most influential descendants
- K142235: CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter (2014), 0 descendants of its own

## Indications for use
The GMCTM device is a gMPSTM enabled intravascular catheter intended for the diagnostic evaluation of the coronary vasculature in patients who are candidates for coronary angiography and/or Percutaneous Coronary Intervention (PCI). The GMCTM is used with compatible gMPSTM system to enable real-time tip positioning and navigation, quantitative length measurement, 3D lumen reconstruction, qualitative 3D foreshortening indication, and landmarking. The System is indicated for use as an adjunct to fluoroscopy.

Source page: https://510kreport.com/device/K091780
Methodology: https://510kreport.com/methodology