đź“‹ FDA Reference
Endovance Dualpass Tear-Away Sheath Introducer
Guidant Cardiac And Vascular Surgery
Summary: The Endovance Dualpass Tear-away 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 cardiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K002676 ↗
Decision Date ?
October 30, 2000
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Endovance Dualpass Tear-away Sheath Introducer was cleared through the FDA 510(k) pathway on October 30, 2000. It is manufactured by Guidant Cardiac And Vascular Surgery and classified as a Class II device.
What It Is
The Endovance Dualpass Tear-away Sheath Introducer is designed to assist in the placement of catheters and other devices into the vascular system. It features a tear-away sheath that allows for easy removal once the catheter is in place. This device is particularly useful in procedures requiring precise vascular access and minimizes trauma to the vessel.
FDA-Cleared Indications
- Provides vascular access for the introduction of catheters and other intravascular devices during interventional procedures.
- Facilitates placement of devices used in procedures involving embolization and other catheter-based vascular interventions.
- Intended for use with compatible catheters or devices of appropriate size.
Clinical Applications
- Obtaining and maintaining vascular access during catheter-based interventions.
- Introducing embolization catheters or other compatible devices into the vascular system.
- Supporting interventional cardiology and vascular procedures that require placement of a catheter followed by sheath removal.
- Providing access for procedures performed in a catheterization laboratory or interventional procedure suite.
Practical Considerations
- The sheath size must match the outside diameter and compatibility requirements of the catheter or device being introduced.
- The operator should use imaging guidance and standard sterile vascular-access technique appropriate to the procedure.
- The tear-away mechanism requires controlled splitting and removal after the catheter or device is in the desired position.
- Potential access-site complications include bleeding, hematoma, infection, arterial or venous injury, thrombosis and, rarely, vessel perforation.
- MRI safety depends on the exact product materials and labeling. Confirm the device-specific MRI information before scanning; do not assume that a device is MRI safe or MRI conditional.
Procedures that use this device
Frequently Asked Questions
What is the Endovance Dualpass Tear-away Sheath Introducer used for?
It is used to facilitate the insertion of catheters or other devices into the vascular system, particularly in procedures like embolization.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as the insertion of embolization coils.
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.