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novoste pulse plus blood containment device
Novoste
Summary: The Novoste Pulse Plus Blood Containment Device is used in interventional radiology for embolization procedures. It is primarily utilized by radiologists and vascular surgeons to manage blood flow during interventions.
FDA Clearance Information
Pathway
510K
Number
K942977 ↗
Decision Date
December 28, 1995
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Novoste Pulse Plus Blood Containment Device was cleared through the FDA 510(k) pathway on December 28, 1995. Manufactured by Novoste, it is classified as a Class 2 device under product code DYB.
What It Is
The Novoste Pulse Plus Blood Containment Device is designed to manage blood flow during embolization procedures. It functions by containing and controlling blood flow to allow for precise placement of embolization coils. This device is essential in procedures where targeted embolization is required to treat vascular abnormalities or control bleeding.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures such as the treatment of aneurysms, arteriovenous malformations, and other vascular lesions. The device is particularly useful in hospitals and specialized clinics where minimally invasive techniques are preferred for managing complex vascular conditions.
Indications for Use
The device is indicated for use in patients requiring embolization to control or redirect blood flow. This includes conditions such as aneurysms or vascular malformations where precise control of blood flow is necessary to prevent complications.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters and clinical needs. It is compatible with standard embolization coils and requires careful handling to ensure proper placement and function during procedures.
Frequently Asked Questions
What is the Novoste Pulse Plus Blood Containment Device used for?
It is used for managing blood flow during embolization procedures, particularly in treating vascular abnormalities.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for use in embolization procedures to control or redirect blood flow in conditions like aneurysms and 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.