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scoutpro hemostatic valve
Biotronik
Summary: The scoutpro hemostatic valve by Biotronik is a medical device used to control bleeding during venous stent procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K101282 ↗
Decision Date
July 21, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The scoutpro hemostatic valve received FDA clearance through the 510(k) pathway on July 21, 2010. It is manufactured by Biotronik and classified as a Class 2 device.
What It Is
The scoutpro hemostatic valve is a device designed to prevent blood loss during procedures involving venous stents. It works by providing a seal around catheters or other instruments inserted into the venous system, maintaining hemostasis while allowing for instrument manipulation. This device is crucial in minimizing blood loss and maintaining a clear field during complex interventions.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings, particularly during procedures involving the placement of venous stents. It is used in hospitals and specialized clinics where vascular interventions are performed. Patients undergoing treatment for venous obstructions or other vascular conditions may benefit from the use of this device.
Indications for Use
The scoutpro hemostatic valve is indicated for use in procedures requiring venous stenting, where maintaining hemostasis is critical. It is suitable for patients undergoing vascular interventions to treat conditions such as venous insufficiency or thrombosis.
Practical Considerations
The scoutpro hemostatic valve is typically compatible with a range of catheter sizes, allowing for versatility in different procedural contexts. Clinicians should ensure compatibility with existing equipment and be familiar with the technique for optimal use.
Frequently Asked Questions
What is scoutpro hemostatic valve used for?
The scoutpro hemostatic valve is used to control bleeding during venous stent procedures, ensuring hemostasis while allowing instrument manipulation.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device during vascular interventions.
What are the FDA-cleared indications?
The device is cleared for use in procedures requiring venous stenting, particularly to maintain hemostasis during such interventions.
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.