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valved peelable introducer
Medamicus
Summary: The valved peelable introducer is a medical device used to facilitate the insertion of catheters into blood vessels while minimizing air embolism risk. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K021004 ↗
Decision Date
June 6, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The valved peelable introducer by Medamicus was cleared via the FDA 510k pathway on June 6, 2002. It is classified as a Class 2 device under product code DYB.
What It Is
The valved peelable introducer is a sheath device designed to aid in the insertion of catheters into the vascular system. It features a valve mechanism that helps prevent air from entering the bloodstream during catheter placement, reducing the risk of air embolism. The peelable design allows for easy removal after catheter insertion, maintaining a sterile field.
Clinical Applications
This device is commonly used in procedures requiring central venous access, such as the placement of central venous catheters, pacemaker leads, or other long-term intravenous therapies. It is frequently utilized in hospital settings, particularly in interventional radiology and cardiology departments. Patients requiring long-term intravenous access or undergoing complex cardiac procedures often benefit from this device.
Indications for Use
The valved peelable introducer is indicated for use in patients requiring vascular access for catheter placement. It is particularly useful in preventing air embolism during the insertion of central venous catheters.
Practical Considerations
The device is typically available in various sizes to accommodate different catheter diameters. It is compatible with standard catheterization techniques and requires careful handling to ensure the valve functions properly. Clinicians should be trained in its use to maximize safety and effectiveness.
Related Literature
The linked study evaluated the air flow through a valved peelable introducer sheath to assess its effectiveness in preventing air embolism. The study found that the valve significantly reduced air flow under various conditions, suggesting it effectively minimizes the risk of air embolism during catheter insertion. However, the study was limited to bench-top evaluations and did not include clinical trials.
Frequently Asked Questions
What is the valved peelable introducer used for?
It is used to facilitate the insertion of catheters into blood vessels while minimizing the risk of air embolism.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring vascular access for catheter placement, particularly to prevent air embolism during central venous catheter insertion.
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.