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bipore accuflex percutaneous sheath introducer
Bipore
Summary: The Bipore Accuflex Percutaneous Sheath Introducer is a medical device used to facilitate the insertion of catheters or other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K964814 ↗
Decision Date
May 7, 1997
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Bipore Accuflex Percutaneous Sheath Introducer was cleared via the FDA 510k pathway on May 7, 1997. Manufactured by Bipore, it is classified as a Class 2 device under product code DYB.
What It Is
The Bipore Accuflex Percutaneous Sheath Introducer is a medical device designed to provide a conduit for the insertion of catheters or other instruments into the vascular system. It consists of a flexible sheath that is inserted percutaneously, allowing for minimally invasive access to blood vessels. This device is particularly useful in procedures requiring the introduction of embolization coils or other interventional tools.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures such as embolization, angiography, and catheter-based interventions. It is suitable for adult and pediatric patients requiring vascular access for diagnostic or therapeutic purposes. The introducer is typically used in hospitals and outpatient surgical centers.
Indications for Use
The FDA-cleared indications for this device include facilitating the introduction of catheters and other devices into the vascular system. It is intended for patients requiring vascular access for procedures like embolization or angiography.
Practical Considerations
The Bipore Accuflex introducer is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and interventional tools. Clinicians should be familiar with percutaneous access techniques to ensure safe and effective use.
Frequently Asked Questions
What is the Bipore Accuflex Percutaneous Sheath Introducer used for?
It is used to facilitate the insertion of catheters or other devices into the vascular system for procedures like embolization and angiography.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system for diagnostic and therapeutic procedures.
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.