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coraforce microcatheter coraflex microcatheter
Reflow Medical
FDA Clearance Information
Pathway
510K
Number
K251277 ↗
Decision Date
August 22, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Coraforce Microcatheter by Reflow Medical received FDA clearance through the 510(k) pathway on August 22, 2025. It is classified as a Class 2 device under product code DQY.
What It Is
The Coraforce Microcatheter is designed for use in venous stenting procedures. It facilitates the delivery of therapeutic agents or devices to targeted vascular sites, aiding in the treatment of vascular occlusions.
Frequently Asked Questions
What are the clinical indications for Coraforce Microcatheter?
The Coraforce Microcatheter is indicated for use in venous stenting procedures, particularly in the recanalization of occluded central veins and aneurysm coiling.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful recanalization of occluded veins and effective aneurysm coiling, demonstrating the device's efficacy in vascular interventions.
What complications have been reported?
Reported complications include device entrapment and fracture, highlighting the importance of careful handling during procedures.
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.