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Contract Medical International
Summary: The Catapult Guide Sheath is a medical device used in vascular procedures, primarily for guiding embolization coils. It is utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K250439 ↗
Decision Date
March 16, 2025
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Catapult Guide Sheath, manufactured by Contract Medical International, received FDA clearance via the 510k pathway on March 16, 2025. It is classified as a Class 2 device under product code DYB.
What It Is
The Catapult Guide Sheath is a flexible, tubular device designed to facilitate the delivery of embolization coils and other interventional tools into the vascular system. It comes in various sizes and lengths, allowing for versatility in accessing different vascular territories. The sheath's design helps maintain a stable pathway for devices to reach target sites within the vasculature.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures involving the placement of embolization coils to treat aneurysms or vascular malformations. It is particularly useful in settings where precise navigation through the vasculature is required, such as in cerebral or peripheral artery interventions. The sheath's various lengths make it adaptable for both pediatric and adult populations.
Indications for Use
The Catapult Guide Sheath is indicated for use in procedures requiring the delivery of embolization coils, such as the treatment of aneurysms or vascular malformations. It is suitable for patients needing precise vascular access and device delivery.
Practical Considerations
The Catapult Guide Sheath is available in 4F and 5F sizes, with lengths ranging from 15cm to 130cm, allowing for flexibility in different procedural contexts. It is compatible with a range of embolization coils and other interventional devices. Clinicians should select the appropriate size based on the target vessel and procedure requirements.
Frequently Asked Questions
What is the Catapult Guide Sheath used for?
The Catapult Guide Sheath is used to facilitate the delivery of embolization coils and other interventional devices into the vascular system during procedures like aneurysm treatment.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the Catapult Guide Sheath in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the delivery of embolization coils, such as treating aneurysms or vascular malformations.
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.