đź“‹ FDA Reference
shuttle sl flexor tuohy-borst side-arm introducer set
Cook
Summary: The Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set is a medical device used for vascular access and catheter introduction. It is primarily used by interventional radiologists and cardiologists for procedures involving embolization coils.
FDA Clearance Information
Pathway
510K
Number
K142819 ↗
Decision Date
July 24, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set was cleared through the FDA 510(k) pathway on July 24, 2015. Manufactured by Cook, it is classified as a Class 2 device under product code DYB.
What It Is
The Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set is designed to facilitate the introduction of catheters and other devices into the vascular system. It features a side-arm for easy connection to fluid management systems and a Tuohy-Borst valve to maintain hemostasis during procedures. This device is particularly useful in providing stable and secure access to the vasculature, which is crucial for the precise placement of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings, particularly during procedures that require the placement of embolization coils to treat vascular abnormalities such as aneurysms or arteriovenous malformations. It is suitable for use in hospital catheterization labs and specialized outpatient centers, catering to adult and pediatric patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring vascular access for the introduction of embolization coils. It is intended for patients who need treatment for conditions like aneurysms or other vascular malformations.
Practical Considerations
The Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and embolization devices, and clinicians should ensure proper sizing and technique to maintain hemostasis and minimize complications.
Frequently Asked Questions
What is Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set used for?
It is used for vascular access and the introduction of catheters and embolization coils during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for vascular access and catheter introduction in procedures involving embolization coils, typically for treating vascular abnormalities.
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.