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Cordis 7 French 0 072 I D Ptca Guiding Catheter
Summary: The Cordis 7 French 0.072 I.D. PTCA Guiding Catheter is a medical device used in percutaneous transluminal coronary angioplasty (PTCA) procedures. It is primarily used by interventional cardiologists to guide other instruments to the coronary arteries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K912777 ↗
Decision Date ?
September 20, 1991
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Cordis 7 French PTCA Guiding Catheter was cleared through the FDA's 510(k) pathway on September 20, 1991. Manufactured by Cordis, it is classified as a Class 2 device under the product code DQY.
What It Is
The Cordis 7 French 0.072 I.D. PTCA Guiding Catheter is a specialized catheter designed to facilitate the delivery of interventional devices to the coronary arteries during PTCA procedures. It features a 7 French size, which refers to its outer diameter, and an internal diameter of 0.072 inches, allowing for the passage of various interventional tools. The catheter's design ensures optimal support and stability during procedures.
FDA-Cleared Indications
- Used to guide interventional devices to the coronary arteries during PTCA.
Clinical Applications
- Guiding angioplasty balloons to coronary artery lesions during PTCA.
- Providing catheter support for advancing other interventional devices into the coronary arteries.
- Supporting coronary artery interventions performed in a cardiac catheterization laboratory.
Practical Considerations
- The catheter is 7 French, with a nominal 0.072-inch internal diameter; users should confirm compatibility with the guidewire, balloon, stent-delivery system or other device being advanced.
- The access route, catheter shape and support should be selected by the treating interventional cardiologist according to the coronary anatomy and planned intervention.
- As with other intravascular guiding catheters, potential complications include vascular injury, bleeding, thrombosis, embolization, arrhythmia, coronary dissection or perforation, and infection.
- MRI safety depends on the specific catheter model and whether it remains in the body; the product labeling should be reviewed before MRI. A catheter that has been removed is not an MRI concern.
- This is a single-use, sterile device and is not intended to remain implanted or to provide long-term vascular access.
Frequently Asked Questions
What is the Cordis 7 French 0.072 I.D. PTCA Guiding Catheter used for?
It is used to guide interventional devices to the coronary arteries during PTCA procedures.
What specialties typically use this device?
Interventional cardiologists typically use this device in catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in guiding devices to the coronary arteries during PTCA for patients with 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.