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candeka dukatir sets
Candela Laser
Summary: The Candeka Dukatir Sets are venous stents used primarily in vascular procedures to support veins. They are typically used by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K950635 ↗
Decision Date
March 1, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Candeka Dukatir Sets were cleared through the FDA 510(k) pathway on March 1, 1995, by Candela Laser. This device is classified as a Class 2 medical device.
What It Is
The Candeka Dukatir Sets are specialized venous stents designed to provide structural support to veins. These stents are typically made of a biocompatible metal mesh that can expand to fit the vein's diameter. They are used to treat venous obstructions or insufficiencies by maintaining patency and improving blood flow.
Clinical Applications
These stents are commonly used in procedures addressing chronic venous insufficiency or venous obstructions, often in the lower extremities. They are utilized in settings such as hospitals and specialized vascular clinics. Patients who benefit from these devices often have conditions like deep vein thrombosis or post-thrombotic syndrome.
Indications for Use
The FDA indications for the Candeka Dukatir Sets include use in patients with venous obstructions or insufficiencies. They are particularly indicated for those experiencing compromised blood flow in the veins.
Practical Considerations
Clinicians should consider the appropriate stent size based on the patient's vein diameter. Compatibility with existing vascular intervention tools is generally high, but always verify with the manufacturer's guidelines. Proper technique in deployment is crucial to avoid complications such as stent migration.
Frequently Asked Questions
What is Candeka Dukatir Sets used for?
They are used to treat venous obstructions or insufficiencies by providing structural support to veins.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with venous obstructions or insufficiencies 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.