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 ?
510(k)
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.
FDA-Cleared Indications
- Maintaining hemostasis during catheter-based vascular procedures.
- Providing hemostatic control around an inserted catheter or vascular access device.
Clinical Applications
- Maintaining hemostasis during interventional radiology catheter procedures.
- Maintaining hemostasis during interventional cardiology catheter procedures.
- Providing blood-loss control during catheter placement and manipulation.
- Supporting vascular procedures in which a catheter must remain in place while the access valve is removed.
Practical Considerations
- The valve should be selected to match the catheter or device size and used according to the manufacturer’s instructions.
- Use sterile technique and inspect the valve and packaging before use; do not use a damaged or expired device.
- The peel-away mechanism should be handled carefully to avoid catheter displacement or loss of hemostasis during removal.
- The available FDA record does not establish MRI safety; review current manufacturer labeling before MRI exposure.
- Potential problems include bleeding, air entry, leakage, device damage, catheter displacement, or vascular injury. Contraindications and warnings should be checked in the current instructions for use.
Procedures that use this device
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.