đź“‹ FDA Reference
guiding catheter hemostasis valve cap
Arrow Intl.
Summary: The guiding catheter hemostasis valve cap is a medical device used to prevent blood loss during catheter-based procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K933033 ↗
Decision Date
September 10, 1993
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The guiding catheter hemostasis valve cap by Arrow Intl. was cleared by the FDA through the 510(k) pathway on September 10, 1993. It is classified as a Class 2 device under product code DQY.
What It Is
This device is a hemostasis valve cap designed to be used with guiding catheters. It functions by providing a seal around the catheter, minimizing blood loss during insertion and manipulation. The valve cap is crucial in maintaining a bloodless field, which is essential for the precision required in catheter-based procedures.
Clinical Applications
The guiding catheter hemostasis valve cap is commonly used in interventional cardiology and radiology procedures, such as angioplasty or stent placement. It is employed in settings like hospitals and specialized cardiac centers, where catheter-based interventions are performed. The device is suitable for adult patients undergoing these procedures.
Indications for Use
The FDA indications suggest that this device is used to control blood flow during catheter-based interventions. It is particularly useful in procedures that require repeated catheter exchanges or manipulations.
Practical Considerations
Clinicians should ensure compatibility with the specific guiding catheters being used. The valve cap is typically available in various sizes to fit different catheter diameters. Proper technique in securing the cap is essential to maintain hemostasis.
Frequently Asked Questions
What is the guiding catheter hemostasis valve cap used for?
It is used to prevent blood loss during catheter-based procedures by providing a seal around the catheter.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device during catheter-based interventions.
What are the FDA-cleared indications?
The device is indicated for use in controlling blood flow during catheter-based procedures, particularly those involving repeated catheter exchanges.
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.