đź“‹ FDA Reference
flexor tuohy-borst side-arm introducers shuttle select
Cook
Summary: The Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select by Cook is a medical device used primarily in interventional radiology for embolization procedures. It is designed for use by specialists such as interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K153430 ↗
Decision Date
March 7, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 7, 2016. Manufactured by Cook, it is classified as a Class II device under product code DYB.
What It Is
The Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select is a specialized catheter introducer system. It features a side-arm design that allows for the introduction of embolization coils and other devices into the vascular system. The device is equipped with a Tuohy-Borst valve to maintain hemostasis while allowing for the passage of instruments.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures involving the placement of embolization coils, such as treating aneurysms or arteriovenous malformations. It is typically used in hospital settings, particularly in catheterization labs, and is suitable for adult patients requiring vascular interventions.
Indications for Use
The FDA indications for this device include its use in procedures that require the introduction of embolization coils into the vascular system. It is intended for patients who need embolization to manage conditions like aneurysms or vascular malformations.
Practical Considerations
The Flexor Tuohy-Borst Side-Arm Introducers come in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and embolization devices. Clinicians should be familiar with catheterization techniques and the specific procedural requirements for using this device effectively.
Frequently Asked Questions
What is the Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select used for?
It is used for introducing embolization coils and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of embolization coils into the vascular system, such as treating aneurysms or 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.