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optiseal enpath valved ptfe peelable introducer
Great Batch Medical
Summary: The Optiseal Enpath Valved PTFE Peelable Introducer is a medical device used primarily by interventional radiologists and cardiologists for the insertion of catheters and other devices into the vascular system. It is designed to facilitate smooth and safe access while minimizing blood loss.
FDA Clearance Information
Pathway
510K
Number
K093232 ↗
Decision Date
March 15, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Optiseal Enpath Valved PTFE Peelable Introducer was cleared via the FDA 510(k) pathway on March 15, 2010. Manufactured by Great Batch Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Optiseal Enpath Valved PTFE Peelable Introducer is a specialized medical device designed to provide a valved entry point into the vascular system. It features a peelable sheath made of PTFE, which allows for easy removal after catheter placement. The valve mechanism helps prevent air embolism and blood loss during procedures, enhancing safety and efficiency.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as the placement of embolization coils, central venous catheters, or pacemaker leads. It is frequently utilized in interventional radiology and cardiology settings, particularly in hospitals and specialized clinics. Patients who require minimally invasive vascular interventions are typical candidates for its use.
Indications for Use
The FDA-cleared indications for this device include facilitating the insertion of catheters and other medical devices into the vascular system. It is particularly useful for patients undergoing procedures that require precise vascular access.
Practical Considerations
The introducer is available in various sizes to accommodate different catheter diameters and patient anatomies. Clinicians should ensure compatibility with the devices being introduced and be familiar with the peel-away technique to ensure safe removal after catheter placement.
Frequently Asked Questions
What is the Optiseal Enpath Valved PTFE Peelable Introducer used for?
It is used for facilitating the insertion of catheters and other medical devices into the vascular system, minimizing blood loss and preventing air embolism.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the insertion of catheters and other devices into the vascular system, particularly in procedures requiring precise 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.