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
510K
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.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery for procedures such as embolization, where precise catheter placement is crucial. It is suitable for use in hospital settings, particularly in catheterization labs. The device is used in a wide range of patient populations requiring vascular interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring vascular access, such as the insertion of embolization coils. It is suitable for patients needing interventions that involve the vascular system.
Practical Considerations
The Endovance Dualpass Tear-away Sheath Introducer is available in various sizes to accommodate different catheter diameters. It is important to select the appropriate size for the procedure to ensure compatibility and minimize vascular trauma. Clinicians should be familiar with the tear-away technique to optimize device use.
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.