📊 Evidence-Based Reference
Medtronic Gc IV Coronary Guiding Catheter
Medtronics Interventional Vascular
Summary: The Medtronic GC IV Coronary Guiding Catheter is a device used in coronary interventions to guide other instruments to the heart. It is FDA 510k cleared and has been studied in clinical settings, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K950490 ↗
Decision Date ?
November 21, 1995
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Medtronic GC IV Coronary Guiding Catheter was cleared by the FDA via the 510k pathway on November 21, 1995. It is manufactured by Medtronics Interventional Vascular and classified as a Class 2 device.
What It Is
The Medtronic GC IV Coronary Guiding Catheter is designed to facilitate the delivery of interventional devices to the coronary arteries. It is used in procedures such as angioplasty and stent placement, providing support and stability for other instruments.
FDA-Cleared Indications
- Percutaneous catheter use in the cardiovascular system under the FDA product classification for catheter, percutaneous devices.
- Use as a guiding catheter to provide access and support for other interventional devices during coronary catheter-based procedures, consistent with the device description.
Clinical Applications
- Providing a conduit for delivery of angioplasty balloons during percutaneous coronary intervention.
- Supporting delivery of coronary stents to a target coronary artery.
- Maintaining catheter position and device support during diagnostic or therapeutic coronary catheterization.
- Navigating and delivering compatible interventional devices through the coronary arterial system.
Evidence Summary
The available literature includes two studies, though neither directly evaluates the Medtronic GC IV Coronary Guiding Catheter. The studies span from 2023 to 2025 and involve various clinical contexts unrelated to the catheter.
Reported Outcomes
Published studies report no direct outcomes related to the Medtronic GC IV Coronary Guiding Catheter. The linked studies focus on unrelated clinical topics, providing no efficacy data for this specific device.
Safety Profile
Reported complications include no specific safety data for the Medtronic GC IV Coronary Guiding Catheter. The linked studies do not address adverse events related to this device.
Evidence Limitations
The evidence for the Medtronic GC IV Coronary Guiding Catheter is limited, with no direct studies evaluating its efficacy or safety. Further research is needed to establish comprehensive clinical outcomes and safety profiles.
Practical Considerations
- The appropriate catheter size, curve, length and lumen diameter depend on the access route, coronary anatomy and interventional device being delivered.
- Compatibility should be confirmed with the intended guidewire, balloon, stent, contrast agent and other equipment before use.
- The catheter is typically inserted through arterial access, commonly the radial or femoral artery, and advanced under fluoroscopic imaging.
- MRI safety information is not provided in the available FDA record. The device should be treated as having unknown MR safety status unless current manufacturer labeling confirms that it is MR Safe or MR Conditional.
- Potential complications of coronary guiding-catheter use include bleeding or vascular injury at the access site, vessel dissection or spasm, thrombosis, embolization, arrhythmia, contrast reaction and, rarely, myocardial infarction or stroke.
Frequently Asked Questions
What are the clinical indications for Medtronic GC IV Coronary Guiding Catheter?
The catheter is indicated for use in coronary interventions, such as angioplasty and stent placement, to guide interventional devices to the coronary arteries.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the provided evidence for the Medtronic GC IV Coronary Guiding Catheter.
What complications have been reported?
No specific complications have been reported in the provided evidence for the Medtronic GC IV Coronary Guiding Catheter.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.