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captiva blood containment device cn100 can19t71w
Merit Medical Systems
Summary: The Captiva Blood Containment Device CN100 is used in embolization procedures to manage blood flow. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K031922 ↗
Decision Date
October 1, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Captiva Blood Containment Device CN100 was cleared by the FDA via the 510(k) pathway on October 1, 2003. It is manufactured by Merit Medical Systems and is classified as a Class 2 device.
What It Is
The Captiva Blood Containment Device CN100 is designed to control and contain blood flow during embolization procedures. It works by capturing and isolating blood, allowing for precise placement of embolic materials. This device is crucial in procedures where blood flow needs to be temporarily halted to treat vascular abnormalities.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery to perform embolization procedures, such as treating aneurysms or arteriovenous malformations. It is particularly useful in settings where precise control over blood flow is necessary, such as in hospitals and specialized surgical centers. Patients with vascular conditions that require embolization are typical candidates.
Indications for Use
The FDA indications suggest that this device is used for procedures requiring blood flow management, particularly in embolization. It is suitable for patients with conditions like aneurysms or vascular malformations where controlling blood flow is critical.
Practical Considerations
The Captiva Blood Containment Device CN100 is typically available in various sizes to accommodate different vessel diameters. It is compatible with standard embolization techniques and materials. Clinicians should ensure proper sizing and compatibility with the specific embolic agents being used.
Frequently Asked Questions
What is the Captiva Blood Containment Device CN100 used for?
It is used to control and contain blood flow during embolization procedures, allowing for precise placement of embolic materials.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures where managing blood flow is necessary, such as in treating aneurysms or vascular malformations.
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.