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peel away split sheath percu cath introducer set
Teleflex
Summary: The peel away split sheath percu cath introducer set is a medical device used to facilitate the insertion of catheters into blood vessels. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K860307 ↗
Decision Date
May 20, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The peel away split sheath percu cath introducer set by Teleflex was cleared through the FDA 510(k) pathway on May 20, 1986. It is classified as a Class 2 device under product code DYB.
What It Is
This device is a peel away split sheath introducer set designed to aid in the percutaneous insertion of catheters into blood vessels. The device features a sheath that can be split and peeled away once the catheter is in place, minimizing trauma to the vessel and allowing for easy removal. It is particularly useful in procedures requiring the placement of central venous catheters or other vascular access devices.
Clinical Applications
The peel away split sheath introducer set is frequently used in interventional radiology and cardiology for procedures such as central venous catheterization, pacemaker lead insertion, and embolization. It is suitable for use in hospital settings, particularly in operating rooms and catheterization labs. The device is used in adult and pediatric patient populations requiring vascular access.
Indications for Use
The device is indicated for use in patients who require percutaneous catheter insertion into blood vessels. This includes conditions where central venous access is necessary, such as for the administration of medications, fluids, or for monitoring central venous pressure.
Practical Considerations
The introducer set is available in various sizes to accommodate different catheter diameters and patient anatomies. Clinicians should ensure compatibility with the catheters being used and be familiar with the peel away technique to minimize vessel trauma during removal.
Frequently Asked Questions
What is the peel away split sheath percu cath introducer set used for?
It is used to facilitate the insertion of catheters into blood vessels, commonly for central venous access.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for percutaneous catheter insertion into blood vessels, such as for central venous 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.