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isaac neurovascular navigation catheter
Microvention
Summary: The isaac neurovascular navigation catheter by Microvention is a Class 2 medical device used for navigating the neurovascular system, primarily by interventional radiologists and neurosurgeons. It aids in procedures involving venous stents.
FDA Clearance Information
Pathway
510K
Number
K222115 ↗
Decision Date
January 10, 2023
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The isaac neurovascular navigation catheter was cleared through the FDA 510k pathway on January 10, 2023. Manufactured by Microvention, it is classified as a Class 2 device under product code DQY.
What It Is
The isaac neurovascular navigation catheter is a specialized catheter designed to facilitate navigation within the neurovascular system. It is used to access and treat conditions within the brain's vascular network. The catheter's design allows for precise maneuverability, which is crucial in delicate neurovascular procedures.
Clinical Applications
This device is commonly used in procedures requiring the placement of venous stents, particularly in the treatment of conditions like cerebral venous sinus thrombosis or other venous obstructions. It is typically employed in hospital settings by specialists such as interventional radiologists and neurosurgeons. The catheter assists in safely navigating complex vascular pathways to reach targeted areas.
Indications for Use
The isaac neurovascular navigation catheter is indicated for use in patients requiring neurovascular navigation, particularly where venous stenting is necessary. It is suitable for conditions involving venous blockages or abnormalities in the brain.
Practical Considerations
Clinicians should consider the catheter's compatibility with existing stenting systems and ensure appropriate sizing for the patient's vascular anatomy. Familiarity with advanced catheterization techniques is recommended to maximize the device's efficacy and safety.
Frequently Asked Questions
What is the isaac neurovascular navigation catheter used for?
It is used for navigating the neurovascular system, particularly in procedures involving venous stents.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for neurovascular navigation in procedures requiring venous stenting, such as in cases of cerebral venous sinus thrombosis.
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.