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Coraforce Microcatheter Coraflex Microcatheter
Summary: The Coraforce Microcatheter, also identified in the record as the Coraflex Microcatheter, is a catheter used to access targeted blood vessels during venous interventions. Reflow Medical received FDA 510(k) clearance for this Class II percutaneous catheter in 2025.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K251277 ↗
Decision Date ?
August 22, 2025
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used in venous stenting procedures.
- Facilitates delivery of therapeutic agents or devices to targeted vascular sites.
- Used to aid treatment of vascular occlusions.
Clinical Applications
- Catheter access during iliac or central venous stenting.
- Delivery of therapeutic agents to a targeted venous site.
- Delivery of interventional devices to a targeted vascular site.
- Access during treatment of venous vascular occlusions.
Practical Considerations
- The specific catheter diameter, length, distal configuration and compatible guidewire or accessory devices should be confirmed in the current manufacturer instructions for use.
- Use requires fluoroscopic or other appropriate vascular imaging guidance and standard sterile catheterization technique.
- MRI safety depends on the exact device configuration and labeling; verify the current MRI conditions before scanning.
- Contraindications, warnings and compatibility requirements should be reviewed in the current instructions for use.
- The catheter is a procedural device and is not intended to remain implanted after the intervention unless the labeling specifically states otherwise.
Procedures that use this device
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.