đź“‹ FDA Reference
ptfe portable introducer
Great Batch Medical
Summary: The PTFE Portable Introducer by Great Batch Medical is a Class 2 medical device used primarily in interventional radiology and cardiology for vascular access. It is designed for use by trained healthcare professionals to facilitate the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K102540 ↗
Decision Date
November 16, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The PTFE Portable Introducer was cleared through the FDA 510(k) pathway on November 16, 2010. Manufactured by Great Batch Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The PTFE Portable Introducer is a medical device used to facilitate the insertion of catheters and other instruments into the vascular system. Made from polytetrafluoroethylene (PTFE), it provides a smooth, low-friction surface that aids in the safe and efficient introduction of devices. Its portability makes it suitable for use in various clinical settings, including hospitals and outpatient facilities.
Clinical Applications
This device is commonly used in procedures requiring vascular access, such as the placement of embolization coils or other interventional radiology techniques. It is frequently utilized by interventional radiologists, cardiologists, and vascular surgeons. The introducer is suitable for a wide range of patient populations, including those undergoing minimally invasive procedures for conditions like aneurysms or vascular malformations.
Indications for Use
The FDA indications suggest that the PTFE Portable Introducer is intended for use in facilitating the introduction of catheters and other devices into the vascular system. It is particularly useful in procedures that require precise and safe vascular access.
Practical Considerations
Clinicians should be aware of the typical sizing options available for the PTFE Portable Introducer to ensure compatibility with the devices being introduced. Proper technique is crucial to minimize the risk of vascular injury, and familiarity with the device's handling characteristics can enhance procedural efficiency.
Frequently Asked Questions
What is the PTFE Portable Introducer used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists, cardiologists, and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system.
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.