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intherm radially expanding dilating introducer
Innerdyne Medical
Summary: The intherm radially expanding dilating introducer is a medical device used to facilitate the insertion of catheters or other instruments into blood vessels. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K931489 ↗
Decision Date
October 15, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The intherm radially expanding dilating introducer was cleared through the FDA 510(k) pathway on October 15, 1993. It is manufactured by Innerdyne Medical and classified as a Class 2 device under product code DYB.
What It Is
The intherm radially expanding dilating introducer is a specialized medical device designed to assist in the insertion of catheters and other instruments into blood vessels. It works by gradually expanding the vessel opening, minimizing trauma and reducing the risk of vessel damage. This device is particularly useful in procedures requiring precise vascular access.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures such as embolization, where precise catheter placement is critical. It is suitable for use in both hospital and outpatient settings, and is often employed in patients requiring vascular interventions, such as those with aneurysms or vascular malformations.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in procedures requiring vascular access, particularly where dilation of the vessel is necessary to accommodate other instruments. It is suitable for patients undergoing embolization or similar interventions.
Practical Considerations
Clinicians should consider the typical sizing of the introducer to ensure compatibility with the intended catheters or instruments. Proper technique is essential to minimize vessel trauma, and familiarity with the device's expanding mechanism is recommended for optimal use.
Frequently Asked Questions
What is intherm radially expanding dilating introducer used for?
It is used to facilitate the insertion of catheters or other instruments into blood vessels by expanding the vessel opening.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access and dilation, such as embolization.
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.