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hemostasis valve with or without side port
Oscor Medical
Summary: The hemostasis valve by Oscor Medical is a device used to control bleeding during vascular procedures. It is primarily used in embolization-coils procedures. Key evidence highlights its effectiveness in achieving hemostasis with minimal complications.
FDA Clearance Information
Pathway
510K
Number
K890277 ↗
Decision Date
March 10, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The hemostasis valve by Oscor Medical was cleared through the FDA 510(k) pathway on March 10, 1989. It is classified as a Class 2 medical device under product code DYB.
What It Is
The hemostasis valve is a medical device designed to prevent blood loss during vascular procedures. It functions by providing a seal around catheters or other instruments inserted into blood vessels. It is intended for use in procedures requiring vascular access, such as embolization-coils.
Clinical Applications
Commonly used in interventional radiology and cardiology, the hemostasis valve is employed in procedures that require the insertion of catheters or other instruments into blood vessels. It is particularly useful in embolization-coils procedures to maintain hemostasis.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs, prospective, and retrospective studies. These studies span from 2019 to 2024, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the hemostasis valve is effective in achieving hemostasis during vascular procedures. The device has been shown to reduce bleeding complications and improve procedural outcomes. Its use is associated with high success rates in maintaining vascular access integrity.
Safety Profile
Reported complications include minor bleeding and device-related malfunctions. However, the incidence of serious adverse events is low, indicating a favorable safety profile for the hemostasis valve in clinical settings.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up in some studies. Further research is needed to evaluate the device's performance in diverse patient populations and complex clinical scenarios.
Frequently Asked Questions
What are the clinical indications for hemostasis valve?
The hemostasis valve is indicated for use in procedures requiring vascular access, such as embolization-coils, to control bleeding.
What outcomes have been reported in clinical studies?
Studies report effective hemostasis and reduced bleeding complications, with high success rates in maintaining vascular access integrity.
What complications have been reported?
Reported complications include minor bleeding and device-related malfunctions, with a low incidence of serious adverse events.
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.