đź“‹ FDA Reference
sinc support catheter
Reflow Medical
Summary: The sinc support catheter by Reflow Medical is a Class 2 device used in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to aid in the placement of stents within veins.
FDA Clearance Information
Pathway 510K
Number K233350 ↗
Decision Date February 8, 2024
Product Code DQY
Device Class Class 2
Evidence 0 studies
The sinc support catheter received FDA clearance through the 510k pathway on February 8, 2024. Manufactured by Reflow Medical, it is classified as a Class 2 medical device.
What It Is
The sinc support catheter is a specialized catheter designed to provide support during the placement of venous stents. It aids in navigating through the vascular system, offering stability and precision. The device is engineered to facilitate the accurate deployment of stents, especially in complex or tortuous venous anatomy.
Clinical Applications
This device is commonly used in procedures involving venous stenting, such as treating venous obstructions or insufficiencies. It is particularly beneficial in interventional radiology and vascular surgery settings, where precision and support are crucial. Patients with conditions like deep vein thrombosis or chronic venous insufficiency may benefit from procedures involving this catheter.
Indications for Use
The sinc support catheter is indicated for use in procedures requiring venous stenting. It is suitable for patients needing stent placement to address venous blockages or structural issues, aiding in restoring proper blood flow.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard stent delivery systems and requires careful handling to ensure optimal performance during procedures.
Frequently Asked Questions
What is the sinc support catheter used for?
The sinc support catheter is used to provide support and stability during venous stenting procedures, aiding in the accurate placement of stents.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in procedures involving venous stenting.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures to treat conditions like venous obstructions or insufficiencies.
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.