đź“‹ FDA Reference
Confida Adaptive Sheath
Summary: The Confida Adaptive Sheath is a medical device used primarily in interventional radiology and cardiology for procedures involving embolization coils. It is utilized by specialists to facilitate the delivery of therapeutic devices to target sites within the vascular system.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152054 ↗
Decision Date ?
August 7, 2015
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Confida Adaptive Sheath by Medtronic was cleared through the FDA 510(k) pathway on August 7, 2015. It is classified as a Class 2 device under product code DYB.
What It Is
The Confida Adaptive Sheath is a flexible, catheter-like device designed to assist in the delivery of embolization coils and other therapeutic devices to specific sites within the vascular system. It features an adaptive design that allows for ease of navigation through the vascular anatomy, providing clinicians with enhanced control and precision during procedures. This device is particularly useful in complex interventions where access to target sites is challenging.
FDA-Cleared Indications
- Used to facilitate the delivery of embolization coils and other therapeutic devices during intravascular procedures.
- Intended for use when controlled catheter access and device delivery are needed within the vascular system.
Clinical Applications
- Delivery of embolization coils during vascular embolization procedures.
- Support for controlled intravascular delivery of therapeutic devices to a target vessel.
- Use in catheter-based treatment of vascular abnormalities when embolic material or another compatible therapeutic device must be positioned precisely.
Practical Considerations
- Available size and configuration must be matched to the patient's vascular anatomy and the embolization device being delivered.
- Confirm compatibility with the guidewire, catheter, embolization coil, and other equipment before use.
- The device should be handled by clinicians trained in endovascular procedures and advanced through the vasculature under appropriate imaging guidance.
- The FDA record and supplied labeling should be reviewed for contraindications, warnings, sterilization information, and MRI conditions; MRI safety should not be assumed without device-specific labeling.
- It is a single-procedure device unless the manufacturer's labeling specifically states otherwise; follow institutional protocols for disposal and reuse.
Procedures that use this device
Frequently Asked Questions
What is the Confida Adaptive Sheath used for?
The Confida Adaptive Sheath is used to facilitate the delivery of embolization coils and other devices to target sites within the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the Confida Adaptive Sheath in procedures involving vascular interventions.
What are the FDA-cleared indications?
The FDA-cleared indications include the use of the Confida Adaptive Sheath for delivering embolization coils to treat vascular conditions such as aneurysms or arteriovenous 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.