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ceres pta catheter models pta018 pta035 various sizes
Ceres Medical Systems
Summary: The Ceres PTA Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to treat vascular conditions. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K060927 ↗
Decision Date
October 6, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Ceres PTA Catheter was cleared through the FDA 510(k) pathway on October 6, 2006. It is manufactured by Ceres Medical Systems and classified as a Class 2 device.
What It Is
The Ceres PTA Catheter is a balloon catheter designed for percutaneous transluminal angioplasty (PTA) procedures. It is used to dilate narrowed or obstructed blood vessels, improving blood flow. The catheter is inserted into the vascular system and navigated to the target site, where the balloon is inflated to open the vessel.
Clinical Applications
This device is commonly used in procedures to treat peripheral artery disease (PAD) and other vascular conditions. It is utilized in settings such as hospitals and outpatient surgical centers, primarily by specialists in interventional radiology and vascular surgery. Patients with atherosclerosis or other forms of vascular stenosis are typical candidates for its use.
Indications for Use
The FDA indications for the Ceres PTA Catheter include its use in dilating stenotic segments of the vascular system. It is intended for patients with conditions like peripheral artery disease where blood flow needs to be restored.
Practical Considerations
The Ceres PTA Catheter comes in various sizes to accommodate different vessel diameters and lengths. Clinicians should consider vessel size and lesion characteristics when selecting the appropriate catheter. Compatibility with standard guidewires and introducer sheaths is typical.
Frequently Asked Questions
What is the Ceres PTA Catheter used for?
The Ceres PTA Catheter is used for percutaneous transluminal angioplasty to treat narrowed or blocked blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for dilating stenotic segments of the vascular system to improve 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.