đź“‹ FDA Reference
Sinc Support Catheter
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 ?
510(k)
Number ?
K233350 ↗
Decision Date ?
February 8, 2024
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter use during endovascular procedures requiring catheter support.
- Support for access, navigation, and delivery of devices within the vascular system.
- Use in procedures involving venous stent placement, when consistent with the device labeling and applicable procedure requirements.
Clinical Applications
- Providing support while navigating venous anatomy during endovascular intervention.
- Supporting delivery and positioning of venous stents.
- Helping maintain catheter stability in tortuous or complex venous anatomy.
- Use during iliac or central venous stenting procedures when the catheter is compatible with the selected stent system.
Practical Considerations
- The appropriate catheter size and length depend on the access site, vessel anatomy, target vein, and device compatibility.
- Compatibility with the selected guidewire, sheath, stent delivery system, and other procedural equipment should be confirmed before use.
- The catheter should be advanced and manipulated under appropriate fluoroscopic or other intravascular imaging guidance by trained clinicians.
- MRI safety information is device-specific and should be confirmed in the current manufacturer instructions for use before an MRI examination.
- Contraindications, warnings, and handling requirements are provided in the manufacturer’s instructions for use; general risks include bleeding, vascular injury, thrombosis, infection, and device malfunction.
Procedures that use this device
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.