📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of catheter insertion into blood vessels
- Facilitation of insertion of other medical devices into blood vessels
Clinical Applications
- Providing vascular access for angiography
- Providing vascular access for embolization procedures
- Providing access for placement or delivery of intravascular devices
- Maintaining a conduit for catheters and guidewires during endovascular procedures
Practical Considerations
- The appropriate sheath diameter and length depend on the target vessel, access route, catheter size, and planned procedure.
- The sheath is generally placed using a guidewire and imaging guidance, commonly through femoral, radial, brachial, or other percutaneous vascular access.
- Compatibility with the intended catheter, guidewire, and other instruments should be confirmed before use.
- Potential access-site complications include bleeding, hematoma, vessel injury, infection, thrombosis, and distal ischemia.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume the device is MRI safe.
Procedures that use this device
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.