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biocardia 8 5 f avance steerable lntroducer
Biocardia
Summary: The Biocardia 8 5 F Avance Steerable Introducer is a medical device used to facilitate the delivery of embolization coils. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K190941 ↗
Decision Date
May 6, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Biocardia 8 5 F Avance Steerable Introducer was cleared through the FDA 510(k) pathway on May 6, 2019. It is manufactured by Biocardia and classified as a Class 2 device.
What It Is
The Biocardia 8 5 F Avance Steerable Introducer is a catheter-like device designed to provide a pathway for the delivery of embolization coils into the vasculature. Its steerable feature allows for precise navigation and placement within the vascular system, which is crucial for successful embolization procedures. The device is constructed to be compatible with standard interventional tools and techniques.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures requiring precise placement of embolization coils, such as in the treatment of aneurysms or arteriovenous malformations. It is particularly useful in complex vascular anatomies where steerability enhances procedural success. The device is suitable for adult patients requiring embolization therapy.
Indications for Use
The FDA indications for this device include facilitating the delivery of embolization coils to treat vascular abnormalities. It is intended for patients with conditions that benefit from embolization, such as aneurysms or abnormal blood vessel formations.
Practical Considerations
The Biocardia 8 5 F Avance Steerable Introducer typically comes in sizes compatible with standard guidewires and embolization coils. Clinicians should be familiar with the device's steerable mechanism to optimize navigation and placement. It is important to ensure compatibility with other interventional tools used during the procedure.
Frequently Asked Questions
What is the Biocardia 8 5 F Avance Steerable Introducer used for?
It is used to facilitate the delivery of embolization coils into the vasculature for procedures like treating aneurysms.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for the delivery of embolization coils to treat vascular abnormalities such as aneurysms.
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.