đź“‹ FDA Reference
corepass modular microcatheter flex corepass modular microcatheter control
Orbusneich Medical (Shenzhen)
Summary: The Corepass Modular Microcatheter is a flexible device used in vascular procedures, particularly for venous stenting. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K242588 ↗
Decision Date
January 7, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Corepass Modular Microcatheter, manufactured by Orbusneich Medical (Shenzhen), received FDA clearance under 510k pathway K242588 on January 7, 2025. It is classified as a Class 2 device.
What It Is
The Corepass Modular Microcatheter is a specialized catheter designed for navigating the vascular system, particularly in venous interventions. Its modular design allows for flexibility and control, making it suitable for accessing difficult-to-reach areas within the venous system. This device is typically used in conjunction with other endovascular tools to facilitate the placement of venous stents.
Clinical Applications
This microcatheter is commonly used in procedures involving the placement of venous stents, such as in the treatment of venous obstructions or thrombosis. Interventional radiologists and vascular surgeons often employ this device in hospital settings, particularly in catheterization labs. It is suitable for adult patients with conditions requiring venous stenting, such as chronic venous insufficiency or post-thrombotic syndrome.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in patients requiring venous stenting. It is particularly useful for those with venous blockages or narrowing that impede normal blood flow.
Practical Considerations
The Corepass Modular Microcatheter is compatible with standard guidewires and stent delivery systems. Clinicians should be aware of the catheter's flexibility and modularity, which can aid in navigating complex venous anatomy. Proper technique in catheter manipulation is essential to maximize its effectiveness.
Frequently Asked Questions
What is the Corepass Modular Microcatheter used for?
It is used for navigating the venous system and facilitating the placement of venous stents.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring venous stenting, particularly for conditions like venous obstructions.
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.