đź“‹ FDA Reference
catapult guide sheath
Contract Medical International
Summary: The Catapult Guide Sheath is a medical device used primarily in interventional radiology and cardiology for procedures like embolization and arrhythmia ablation. It is designed for use by specialists in these fields to navigate and position within the vascular system.
FDA Clearance Information
Pathway 510K
Number K221914 ↗
Decision Date July 29, 2022
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Catapult Guide Sheath was cleared through the FDA 510k pathway on July 29, 2022. Manufactured by Contract Medical International, it is classified as a Class 2 device under product code DYB.
What It Is
The Catapult Guide Sheath is a steerable sheath designed to facilitate the navigation and placement of catheters within the vascular system. It is particularly useful in procedures requiring precise positioning, such as embolization and arrhythmia ablation. The device's design allows for enhanced maneuverability and stability, which is crucial in complex interventional procedures.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings, particularly in procedures involving embolization and electrophysiological interventions. It is suitable for use in hospitals and specialized clinics where such procedures are performed. Patients with conditions requiring vascular access for therapeutic interventions, such as arrhythmias or vascular malformations, may benefit from its use.
Indications for Use
The FDA indications for the Catapult Guide Sheath include its use in procedures requiring vascular access and catheter navigation, such as embolization and arrhythmia ablation. It is intended for patients needing precise catheter placement within the vascular system.
Practical Considerations
The Catapult Guide Sheath comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard catheter systems and requires careful handling to ensure optimal performance. Clinicians should be familiar with its steerable mechanism to maximize its utility.
Related Literature
The linked study investigated the use of a deflectable intracardiac MR imaging guiding-sheath in swine models to enhance imaging during MR-guided electrophysiological interventions. The study demonstrated improved signal-to-noise ratio in cardiac chambers and effective navigation with minimal MR-induced heating. However, the study was limited to animal models, and further research is needed to confirm efficacy and safety in human subjects.
Frequently Asked Questions
What is the Catapult Guide Sheath used for?
It is used for navigating and positioning catheters within the vascular system during procedures like embolization and arrhythmia ablation.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital and specialized clinic settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access and catheter navigation, such as embolization and arrhythmia ablation.
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.