đź“‹ FDA Reference
kodiak dual port coaxial introducer kit
Argon Medical Devices
Summary: The Kodiak Dual Port Coaxial Introducer Kit is a medical device used for vascular access during embolization procedures. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K230631 ↗
Decision Date
May 22, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Kodiak Dual Port Coaxial Introducer Kit, manufactured by Argon Medical Devices, was cleared through the FDA 510(k) pathway on May 22, 2023. It is classified as a Class 2 device under product code DYB.
What It Is
The Kodiak Dual Port Coaxial Introducer Kit is designed to facilitate the insertion of catheters and other devices into the vascular system. It features dual ports for enhanced access and maneuverability during procedures. The coaxial design helps in maintaining stability and precision, which is crucial for successful vascular interventions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for procedures such as embolization, where precise catheter placement is necessary. It is particularly useful in complex vascular cases requiring multiple access points or when dealing with tortuous anatomy. The kit is suitable for adult patients undergoing procedures to treat vascular abnormalities or blockages.
Indications for Use
The FDA indications for the Kodiak Dual Port Coaxial Introducer Kit include its use in facilitating vascular access for embolization procedures. It is intended for patients requiring precise catheter placement for the treatment of vascular conditions.
Practical Considerations
Clinicians should consider the appropriate size of the introducer kit based on the patient's vascular anatomy and the specific procedure. Compatibility with other devices used during the procedure should be verified. Proper technique in handling and insertion is crucial to minimize complications.
Frequently Asked Questions
What is the Kodiak Dual Port Coaxial Introducer Kit used for?
It is used for vascular access during embolization procedures, allowing for precise catheter placement.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access in embolization procedures for treating vascular conditions.
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.