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input 10f 11 f introducer set 010101 10f 011101 11f
C.R. Bard
Summary: The Input 10F 11F Introducer Set by C.R. Bard is a medical device used primarily in vascular procedures to facilitate the introduction of catheters or other devices. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K961135 ↗
Decision Date
April 30, 1996
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Input 10F 11F Introducer Set was cleared through the FDA 510(k) pathway on April 30, 1996. Manufactured by C.R. Bard, it is classified as a Class II device under product code DYB.
What It Is
The Input 10F 11F Introducer Set is a medical device designed to assist in the insertion of catheters or other medical instruments into the vascular system. It typically consists of a sheath and dilator, allowing for smooth and controlled access to blood vessels. This device is crucial in procedures requiring vascular access, minimizing trauma to the vessel and ensuring the safe passage of other devices.
Clinical Applications
This introducer set is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and the deployment of vascular coils. It is utilized in both inpatient and outpatient settings, particularly in hospitals and specialized clinics. The device is suitable for adult patients requiring vascular interventions, including those with conditions like aneurysms or vascular malformations.
Indications for Use
The FDA-cleared indications for this device include facilitating the introduction of catheters and other devices into the vascular system. It is particularly indicated for use in procedures involving embolization coils, which are used to treat aneurysms or block blood flow to certain areas.
Practical Considerations
When using the Input 10F 11F Introducer Set, clinicians should consider the appropriate size for the patient's vascular anatomy. Compatibility with other devices, such as catheters and guidewires, is essential for successful procedures. Proper technique in insertion and handling can reduce the risk of complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the Input 10F 11F Introducer Set used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system, particularly in procedures like angiography and embolization.
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 use in the introduction of catheters and other devices into the vascular system, especially for procedures involving embolization coils.
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.