đź“‹ FDA Reference
cook vascular peel-away hemostasis valve
Cook Vascular
Summary: The Cook Vascular Peel-Away Hemostasis Valve is a medical device used to maintain hemostasis during catheterization procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K010128 ↗
Decision Date
April 25, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cook Vascular Peel-Away Hemostasis Valve was cleared by the FDA via the 510(k) pathway on April 25, 2002. It is manufactured by Cook Vascular and classified as a Class 2 device.
What It Is
The Cook Vascular Peel-Away Hemostasis Valve is a specialized device designed to prevent blood loss during catheter insertion and manipulation. It features a peel-away mechanism that allows for easy removal once the catheter is in place. This device is essential in procedures where maintaining a bloodless field is critical, such as during the placement of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures, particularly during embolization to control bleeding or block blood flow to certain areas. It is suitable for use in hospital settings, especially in catheterization labs, and is typically employed in adult patients undergoing minimally invasive vascular procedures.
Indications for Use
The FDA indications for the Cook Vascular Peel-Away Hemostasis Valve include its use in maintaining hemostasis during catheter-based procedures. It is indicated for patients requiring vascular access where blood loss needs to be minimized.
Practical Considerations
The device is compatible with a range of catheter sizes, making it versatile for various procedures. Clinicians should ensure proper sizing and technique to optimize hemostasis and device performance during use.
Frequently Asked Questions
What is the Cook Vascular Peel-Away Hemostasis Valve used for?
It is used to maintain hemostasis during catheterization procedures, preventing blood loss while allowing catheter manipulation.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for maintaining hemostasis during catheter-based procedures to minimize blood loss.
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.