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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 instruments into blood vessels. It is primarily used by interventional radiologists and cardiologists in procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K051513 ↗
Decision Date
December 7, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Bipore Accuflex Percutaneous Sheath Introducer received FDA clearance through the 510(k) pathway on December 7, 2005. It is manufactured by Bipore and 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 stable and flexible pathway for the insertion of catheters and other instruments into the vascular system. It typically consists of a sheath and dilator, which are used to access blood vessels with minimal trauma. This device is crucial for procedures that require precise vascular access, such as angiography or the placement of embolization coils.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Bipore Accuflex is essential for procedures like angioplasty, stent placement, and embolization. It is used in hospital settings, particularly in catheterization labs, and is suitable for a wide range of patients requiring vascular interventions. Its design allows for smooth insertion and reduced risk of vessel injury, making it ideal for both routine and complex cases.
Indications for Use
The FDA-cleared indications for this device include facilitating the insertion of catheters or other instruments into blood vessels. It is designed for patients needing vascular access for diagnostic or therapeutic procedures, such as those undergoing embolization.
Practical Considerations
The Bipore Accuflex is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with a range of catheters and guidewires, and clinicians should be familiar with the specific technique for sheath insertion to minimize complications. Proper sizing and technique are crucial for optimal performance.
Frequently Asked Questions
What is the Bipore Accuflex Percutaneous Sheath Introducer used for?
It is used to facilitate the insertion of catheters or other instruments into blood vessels during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of catheters or instruments into blood vessels for diagnostic or 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.