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tearaway introducer sheath
Xentek Medical
Summary: The tearaway introducer sheath by Xentek Medical is a device used to facilitate vascular access, primarily in interventional radiology and oncology settings. It is utilized by clinicians to introduce catheters into central veins safely and efficiently.
FDA Clearance Information
Pathway
510K
Number
K000313 ↗
Decision Date
June 16, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The tearaway introducer sheath was cleared through the FDA 510(k) pathway on June 16, 2000. Manufactured by Xentek Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The tearaway introducer sheath is a medical device designed to facilitate the insertion of catheters into the central venous system. It consists of a sheath that can be easily removed or 'torn away' once the catheter is in place, minimizing trauma to the vessel. This device is particularly useful in procedures requiring reliable vascular access, such as chemotherapy administration or long-term intravenous therapy.
Clinical Applications
Commonly used in interventional radiology and oncology, the tearaway introducer sheath is employed in procedures requiring central venous access. It is particularly beneficial for patients needing long-term intravenous treatments, such as those undergoing chemotherapy. The device is used in hospital settings, often by interventional radiologists or oncologists, to ensure safe and efficient catheter placement.
Indications for Use
The FDA indications for the tearaway introducer sheath include its use in facilitating the insertion of catheters into central veins. It is intended for patients requiring reliable vascular access, such as those undergoing treatments that necessitate repeated or prolonged intravenous therapy.
Practical Considerations
The tearaway introducer sheath is available in various sizes to accommodate different catheter dimensions and patient anatomies. It is compatible with standard guidewires and catheters used in central venous access procedures. Clinicians should be familiar with the technique of using a tearaway sheath to ensure successful catheter placement.
Related Literature
The linked study compared Groshong and Hickman catheters in terms of complications such as sepsis and thrombus formation. It highlighted the use of tearaway introducer sheaths in establishing vascular access. The study found no significant difference in septic complications and thrombus formation between the two catheter types, although it noted a significant difference in catheter malfunction rates. Limitations include the study's age and potential changes in device technology since its publication.
Frequently Asked Questions
What is the tearaway introducer sheath used for?
It is used to facilitate the insertion of catheters into central veins, primarily for patients requiring long-term intravenous therapy.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device in hospital settings for vascular access procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating catheter insertion into central veins for patients needing reliable 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.