đź“‹ FDA Reference
Q3 Distal Access Catheter Q4 Distal Access Catheter Q5 Distal Access Catheter Q6DISTAL Access Catheter
Summary: The q3-q6 distal access catheters by Mivi Neurovascular are used in neurovascular procedures to provide distal access within the vasculature. They are typically utilized by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K192558 ↗
Decision Date ?
April 6, 2020
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The q3-q6 distal access catheters were cleared through the FDA 510(k) pathway on April 6, 2020. Manufactured by Mivi Neurovascular, these devices are classified as Class 2 under product code DQY.
What It Is
The q3-q6 distal access catheters are medical devices designed to facilitate access to distal regions of the neurovascular system. These catheters are flexible, allowing navigation through the complex vascular pathways of the brain. They are used to deliver therapeutic agents or to assist in the placement of other devices such as stents.
FDA-Cleared Indications
- To provide distal access within the neurovascular system during interventional procedures.
- For use with compatible guidewires, catheters, and other neurointerventional devices according to the device labeling.
Clinical Applications
- Providing distal access to cerebral blood vessels during neurointerventional procedures.
- Supporting delivery of compatible therapeutic agents or other devices within the neurovascular system.
- Facilitating placement of compatible neurovascular devices, such as stents, when indicated by the treating specialist.
Practical Considerations
- The q3 through q6 models provide different catheter sizes and configurations; the treating specialist selects the appropriate option for the patient's vascular anatomy and the planned procedure.
- The catheter is advanced under real-time fluoroscopic imaging, typically through a vascular access sheath and over a compatible guidewire.
- Compatibility with guidewires, intermediate or microcatheters, stents, aspiration systems, and other devices must be confirmed before use.
- Operators should use careful catheter and guidewire technique to reduce the risk of vessel spasm, dissection, perforation, embolization, or other vascular injury.
- MRI safety and conditional-use information should be confirmed in the current manufacturer instructions for use; the FDA clearance record alone does not establish that the catheter is MR safe.
Frequently Asked Questions
What is q3-q6 distal access catheter used for?
These catheters are used to access distal regions of the neurovascular system for procedures like thrombectomy and stent placement.
What specialties typically use this device?
Interventional radiologists and neurosurgeons specializing in neurovascular procedures commonly use these catheters.
What are the FDA-cleared indications?
These catheters are indicated for providing distal access in the neurovascular system, facilitating procedures such as thrombectomy and stent deployment.
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.