📋 FDA Reference
Gc IV Coronary Guiding Catheter
Medtronics Interventional Vascular
Summary: The gc iv coronary guiding catheter is a medical device used in interventional cardiology for guiding other instruments into coronary arteries. It is primarily used by cardiologists during procedures like angioplasty.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K932933 ↗
Decision Date ?
February 1, 1994
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The gc iv coronary guiding catheter was cleared through the FDA 510k pathway on February 1, 1994. It is manufactured by Medtronics Interventional Vascular and classified as a Class 2 device.
What It Is
The gc iv coronary guiding catheter is a specialized catheter designed to facilitate the navigation and placement of other interventional devices into the coronary arteries. It is typically used in procedures such as percutaneous coronary interventions (PCI) to treat coronary artery disease. The catheter's design allows for optimal flexibility and support, aiding in the precise delivery of balloons, stents, or other therapeutic devices.
FDA-Cleared Indications
- For use as a guiding catheter during percutaneous interventional procedures involving the coronary arteries.
- For facilitating the introduction and guidance of compatible interventional devices to the coronary vasculature.
Clinical Applications
- Guiding balloons during percutaneous coronary angioplasty.
- Guiding coronary stents during percutaneous coronary intervention.
- Providing catheter support and access during diagnostic or therapeutic coronary catheterization.
- Delivering compatible interventional devices through the coronary arteries under fluoroscopic imaging.
Practical Considerations
- The operator should select the catheter's size, curve, length and tip configuration according to the patient's vascular anatomy and the target coronary artery.
- Compatibility with guidewires, balloons, stents, contrast-delivery systems and other interventional devices should be confirmed before use.
- The catheter is manipulated under fluoroscopic imaging by trained clinicians; excessive force can cause vessel injury, spasm, dissection or perforation.
- MRI safety cannot be determined from the available FDA record. The specific device labeling should be reviewed before an MRI examination.
- Contraindications, warnings and precautions in the current manufacturer labeling should be followed, including assessment for contrast allergy, bleeding risk and vascular-access complications.
Related Literature
The linked study from the 36th International Symposium on Intensive Care and Emergency Medicine explored various topics, including the impact of sepsis on capillary response and erythrocyte function. Although not directly related to the guiding catheter, the study highlights the importance of understanding vascular responses in critical care settings. Limitations include its focus on sepsis rather than coronary interventions.
Frequently Asked Questions
What is gc iv coronary guiding catheter used for?
It is used to guide other interventional devices into the coronary arteries during procedures like angioplasty and stent placement.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in guiding interventional devices during procedures within the coronary arteries, particularly for treating coronary artery disease.
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.