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seal-away hemostasis adapter model 406229
Diag
Summary: The Seal-Away Hemostasis Adapter is a medical device used to control bleeding during procedures involving embolization coils. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K984062 ↗
Decision Date
March 24, 1999
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Seal-Away Hemostasis Adapter by Diag was cleared through the FDA 510k pathway on March 24, 1999. It is a Class 2 device under product code DYB.
What It Is
The Seal-Away Hemostasis Adapter is designed to provide hemostasis during procedures that involve the insertion of embolization coils. It functions by sealing the entry site to prevent blood loss while allowing for the passage of interventional tools. This device is particularly useful in maintaining a sterile field and minimizing complications associated with vascular access.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings, particularly during procedures that require the placement of embolization coils to treat vascular abnormalities such as aneurysms or arteriovenous malformations. It is suitable for use in hospitals and specialized clinics, primarily serving adult and pediatric patients undergoing minimally invasive procedures.
Indications for Use
The FDA indications for this device include its use in procedures that require the insertion of embolization coils to control bleeding or block abnormal blood vessels. It is intended for patients who need vascular interventions to treat conditions like aneurysms.
Practical Considerations
The Seal-Away Hemostasis Adapter is compatible with standard catheter sizes used in embolization procedures. Clinicians should ensure proper sizing to maintain hemostasis and prevent air embolism. Familiarity with catheter-based techniques is essential for optimal use.
Frequently Asked Questions
What is the Seal-Away Hemostasis Adapter used for?
It is used to control bleeding during procedures involving embolization coils.
What specialties typically use this device?
Interventional radiology and cardiology specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring embolization coils to control bleeding or block abnormal blood vessels.
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.