đź“‹ FDA Reference
intraoperative balloon dilation cath
Advanced Cardiovascular Systems
Summary: The intraoperative balloon dilation catheter is a medical device used to dilate blood vessels during surgical procedures. It is primarily used by cardiovascular surgeons and interventional radiologists to improve blood flow in patients with vascular obstructions.
FDA Clearance Information
Pathway
510K
Number
K822393 ↗
Decision Date
November 1, 1982
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on November 1, 1982, by Advanced Cardiovascular Systems. It is classified as a Class 2 device under product code DQY.
What It Is
The intraoperative balloon dilation catheter is a specialized tool designed to expand narrowed or obstructed blood vessels during surgery. It consists of a flexible catheter with an inflatable balloon at its tip. When positioned at the site of a blockage, the balloon is inflated to widen the vessel, improving blood flow and facilitating further surgical intervention.
Clinical Applications
This device is commonly used in cardiovascular surgeries, particularly in procedures involving the coronary or peripheral arteries. It is utilized in settings such as operating rooms and catheterization labs, often in patients with atherosclerosis or other vascular diseases. The device is essential for procedures like angioplasty, where precise dilation of vessels is required.
Indications for Use
The FDA indications suggest this device is intended for use in patients with vascular obstructions requiring surgical intervention. It is suitable for conditions like coronary artery disease where vessel dilation can restore adequate blood flow.
Practical Considerations
Clinicians should consider the appropriate size of the balloon catheter based on the target vessel's diameter. Compatibility with other surgical tools and imaging equipment is crucial for effective use. Proper technique in positioning and inflating the balloon is essential to avoid vessel damage.
Frequently Asked Questions
What is the intraoperative balloon dilation catheter used for?
It is used to dilate narrowed or blocked blood vessels during surgical procedures, improving blood flow.
What specialties typically use this device?
Cardiovascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in patients with vascular obstructions needing surgical dilation to restore blood flow.
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.