đź“‹ FDA Reference
scoutpro 8f models 342 262 hemostatic valve models 345 968 hook guiding catheter models 342 263 multi-purpose h
Biotronik
Summary: The scoutpro 8f is a hemostatic valve used in vascular procedures to control bleeding. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K060655 ↗
Decision Date
April 4, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The scoutpro 8f was cleared via the FDA 510(k) pathway on April 4, 2006. Manufactured by Biotronik, it is a Class 2 medical device.
What It Is
The scoutpro 8f is a hemostatic valve designed to minimize blood loss during vascular access procedures. It functions by providing a seal around catheters and other instruments introduced into the vascular system. This device is crucial in maintaining hemostasis while allowing for the passage of diagnostic and therapeutic tools.
Clinical Applications
Commonly used in interventional cardiology and radiology, the scoutpro 8f is employed during procedures such as angiography, stent placement, and other catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs, and is essential for patients undergoing vascular interventions.
Indications for Use
The device is indicated for use in procedures requiring vascular access where controlling blood loss is critical. It is suitable for patients undergoing diagnostic or therapeutic catheterization.
Practical Considerations
The scoutpro 8f is compatible with a variety of catheter sizes, typically around 8 French. Clinicians should ensure compatibility with other instruments used during procedures and be familiar with its operation to optimize hemostatic control.
Frequently Asked Questions
What is the scoutpro 8f used for?
It is used to control bleeding during vascular access procedures by providing a seal around catheters.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access where controlling blood loss is critical.
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.