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mivi 6f guide catheter
Mivi
Summary: The Mivi 6F Guide Catheter is a medical device used for vascular access and support in interventional procedures. It is primarily used by interventional radiologists and neurointerventionalists.
FDA Clearance Information
Pathway
510K
Number
K140557 ↗
Decision Date
September 18, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Mivi 6F Guide Catheter was cleared through the FDA 510(k) pathway on September 18, 2014. It is manufactured by Mivi and classified as a Class 2 device under product code DQY.
What It Is
The Mivi 6F Guide Catheter is a flexible, large-lumen catheter designed to provide stable vascular access during endovascular procedures. It facilitates the delivery of therapeutic devices and contrast agents. Its design emphasizes navigability and support, crucial for procedures requiring precise catheter placement.
Clinical Applications
This device is commonly used in neurointerventional procedures, particularly in the context of acute ischemic stroke where rapid recanalization is critical. It is also applicable in other vascular interventions requiring large-lumen access, such as the placement of venous stents. The catheter is typically used in hospital settings by specialists in interventional radiology and neurology.
Indications for Use
The Mivi 6F Guide Catheter is indicated for use in procedures requiring vascular access and support. It is suitable for patients undergoing interventions for conditions like acute ischemic stroke or other vascular occlusions.
Practical Considerations
The catheter typically comes in various lengths to accommodate different anatomical requirements. It is compatible with standard guidewires and other interventional devices. Clinicians should consider vessel size and tortuosity when selecting the appropriate catheter size.
Related Literature
The linked study evaluated a novel aspiration catheter design for acute stroke thrombectomy, highlighting improved recanalization rates with larger lumen catheters. The study found that the novel design enhanced navigability and efficacy compared to smaller devices. However, the study's limitations include a focus on a specific catheter design and potential variability in operator technique.
Frequently Asked Questions
What is the Mivi 6F Guide Catheter used for?
It is used for providing vascular access and support during interventional procedures, particularly in neurovascular interventions.
What specialties typically use this device?
Interventional radiologists and neurointerventionalists commonly use this device.
What are the FDA-cleared indications?
The device is cleared for use in procedures requiring vascular access and support, such as interventions for acute ischemic stroke.
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.