đź“‹ FDA Reference
sat centerflow molding balloon catheter in20-00313
Strait Access Technologies Holdings
Summary: The sat centerflow molding balloon catheter is a medical device used primarily in venous stenting procedures. It is utilized by interventional radiologists and vascular surgeons to assist in the placement and expansion of stents within veins.
FDA Clearance Information
Pathway
510K
Number
K243184 ↗
Decision Date
June 25, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The sat centerflow molding balloon catheter by Strait Access Technologies was cleared through the FDA 510(k) pathway on June 25, 2025. It is a Class 2 device under product code DQY.
What It Is
The sat centerflow molding balloon catheter is a specialized catheter designed to aid in the deployment and expansion of venous stents. It features a balloon component that can be inflated to mold and secure stents in place within the venous system. This device is crucial in ensuring the proper positioning and expansion of stents, which helps maintain venous patency and improve blood flow.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings for procedures involving venous stenting. It is particularly useful in treating conditions such as chronic venous insufficiency or venous obstructions. The device is typically used in hospitals or outpatient surgical centers, and it is suitable for adult patients requiring venous stent placement.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring the placement and expansion of stents within veins. It is intended for patients with conditions that necessitate venous stenting to restore or improve venous blood flow.
Practical Considerations
Clinicians should consider the appropriate sizing of the balloon catheter to match the stent and venous anatomy. Compatibility with various stent types should be verified, and proper technique is essential to ensure successful stent deployment and expansion.
Frequently Asked Questions
What is the sat centerflow molding balloon catheter used for?
It is used for the placement and expansion of venous stents to treat conditions like venous obstructions.
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 use in venous stenting procedures to improve venous 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.