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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 blood vessels. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K073434 ↗
Decision Date
April 1, 2008
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Bipore Accuflex Percutaneous Sheath Introducer was cleared through the FDA 510(k) pathway on April 1, 2008. 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 aid in the insertion of catheters into the vascular system. It consists of a flexible sheath that provides a stable conduit for the passage of various medical instruments. This device is particularly useful in procedures requiring vascular access, ensuring minimal trauma to the vessel and reducing the risk of complications.
Clinical Applications
This device is commonly used in interventional cardiology and radiology procedures, such as angiography, embolization, and stent placement. It is frequently employed in hospital settings, particularly in catheterization labs and interventional suites. The introducer is suitable for a wide range of patients requiring vascular access, from those undergoing diagnostic imaging to those receiving therapeutic interventions.
Indications for Use
The FDA has cleared this device for use in facilitating the insertion of catheters and other devices into blood vessels. It is indicated for patients needing vascular access for procedures like angiography or embolization.
Practical Considerations
The Bipore Accuflex is available in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with a range of catheters and guidewires, making it versatile for various interventional techniques. Proper technique is essential to minimize vascular trauma and ensure successful device placement.
Frequently Asked Questions
What is the Bipore Accuflex Percutaneous Sheath Introducer used for?
It is used to facilitate the insertion of catheters and other medical devices into blood vessels for diagnostic and therapeutic 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 into blood vessels, particularly for procedures like angiography and embolization.
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.