đź“‹ FDA Reference
Equaflow Multivalve Infusion Catheter
Summary: The Equaflow Multivalve Infusion Catheter by Cook is a Class 2 medical device used primarily for embolization procedures. It is utilized by interventional radiologists and vascular surgeons to deliver embolic agents precisely.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K123235 ↗
Decision Date ?
February 14, 2013
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Equaflow Multivalve Infusion Catheter was cleared through the FDA 510(k) pathway on February 14, 2013. Manufactured by Cook, it is classified as a Class 2 device under product code DYB.
What It Is
The Equaflow Multivalve Infusion Catheter is a specialized catheter designed to deliver embolic agents to specific vascular sites. It features multiple valves that allow for controlled infusion, enhancing precision during embolization procedures. This device is particularly useful in managing vascular abnormalities by occluding blood vessels with embolic materials.
FDA-Cleared Indications
- Delivery of embolic agents during vascular embolization procedures
- Targeted occlusion of blood vessels when embolization is clinically indicated
Clinical Applications
- Selective delivery of embolic agents to a target artery or vascular territory
- Embolization to reduce or stop blood flow through abnormal or unwanted vessels
- Catheter-based treatment of vascular conditions for which embolization is indicated
Reported off-label uses
- Use in selected embolization procedures involving uterine, prostatic, ovarian, or gonadal vessels may be considered off label depending on the device labeling and embolic agent used
- Use for embolization of tumors, arteriovenous malformations, aneurysms, or gastrointestinal bleeding may be off label unless specifically included in the applicable labeling
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The catheter is available in different configurations and sizes; selection depends on vessel diameter, access route, target anatomy, and the embolic agent.
- It is intended for use with compatible embolic materials and requires fluoroscopic or other appropriate imaging guidance.
- The operator must confirm catheter position and maintain careful control during embolic delivery to reduce the risk of non-target embolization, vessel injury, or catheter obstruction.
- MRI safety and conditional-use information should be confirmed in the current Cook instructions for use; do not assume the catheter is safe for MRI after placement or while it remains in the body.
- Contraindications, warnings, and compatibility limitations should be reviewed in the current manufacturer labeling before use.
Procedures that use this device
Frequently Asked Questions
What is the Equaflow Multivalve Infusion Catheter used for?
It is used for delivering embolic agents during embolization procedures to occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to occlude blood vessels in patients with vascular abnormalities.
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.