đź“‹ FDA Reference
enpath medical viaseal valved peelable introducer model 10866-xxx
Enpath Medical
Summary: The Viaseal Valved Peelable Introducer by Enpath Medical is a device used to facilitate the insertion of catheters and other medical instruments into the body. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K063182 ↗
Decision Date
December 21, 2006
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Viaseal Valved Peelable Introducer, manufactured by Enpath Medical, was cleared through the FDA 510k pathway on December 21, 2006. It is classified as a Class 2 medical device under product code DYB.
What It Is
The Viaseal Valved Peelable Introducer is a medical device designed to provide a conduit for the insertion of catheters and other instruments into the vascular system. It features a peelable sheath with a valve that helps maintain hemostasis during procedures. This device is particularly useful in minimizing blood loss and reducing the risk of air embolism during catheterization.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as the placement of embolization coils or other vascular interventions. It is suitable for use in hospital settings, particularly in catheterization labs, and is used for patients requiring vascular access for diagnostic or therapeutic procedures.
Indications for Use
The FDA indications for this device include its use in facilitating the insertion of catheters and other medical instruments into the vascular system. It is intended for patients undergoing procedures that require vascular access.
Practical Considerations
The Viaseal Valved Peelable Introducer is available in various sizes to accommodate different catheter diameters. It is compatible with a range of catheter types and is designed to be easy to use, with a focus on maintaining hemostasis and reducing the risk of complications during insertion.
Frequently Asked Questions
What is the Viaseal Valved Peelable Introducer used for?
It is used to facilitate the insertion of catheters and other medical instruments into the vascular system, helping to maintain hemostasis during procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings, particularly in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of catheters and other medical instruments into the vascular system for patients requiring vascular access.
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.