đź“‹ FDA Reference
smith medical peel-away sheath introducers
Smiths Medical Md
Summary: The Smith Medical Peel-Away Sheath Introducers are used to facilitate the insertion of catheters and other medical devices into blood vessels. They are primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K112407 ↗
Decision Date
February 9, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Smith Medical Peel-Away Sheath Introducers were cleared through the FDA 510(k) pathway on February 9, 2012. Manufactured by Smiths Medical Md, this Class 2 device is categorized under product code DYB.
What It Is
The Smith Medical Peel-Away Sheath Introducers are medical devices designed to aid in the insertion of catheters into blood vessels. These introducers consist of a sheath that can be peeled away once the catheter is in place, minimizing trauma to the vessel. This feature is particularly useful in procedures requiring precise catheter placement.
Clinical Applications
These introducers are commonly used in interventional radiology and cardiology for procedures such as embolization or the placement of central venous catheters. They are suitable for use in both hospital and outpatient settings, catering to a wide range of patient populations, including those requiring long-term vascular access.
Indications for Use
The FDA indications for the Smith Medical Peel-Away Sheath Introducers include facilitating the insertion of catheters into blood vessels. They are used in patients who require vascular access for procedures like embolization or catheter-based interventions.
Practical Considerations
The introducers come in various sizes to accommodate different catheter diameters and vessel sizes. They are compatible with a wide range of catheters and are designed for easy handling and minimal vessel trauma during insertion. Clinicians should ensure proper technique to avoid complications.
Frequently Asked Questions
What is Smith Medical Peel-Away Sheath Introducers used for?
They are used to facilitate the insertion of catheters into blood vessels, commonly in interventional radiology and cardiology procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device for catheter-based procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the insertion of catheters into blood vessels, particularly in procedures requiring vascular access.
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.