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inner-lock locking introducer sheaths
Rex Medical
Summary: The Inner-Lock Locking Introducer Sheaths by Rex Medical are used for vascular access in interventional procedures, particularly in embolization. They are typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K022170 ↗
Decision Date
January 21, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Inner-Lock Locking Introducer Sheaths were cleared through the FDA 510(k) pathway on January 21, 2003. Manufactured by Rex Medical, this Class 2 device is categorized under product code DYB.
What It Is
The Inner-Lock Locking Introducer Sheaths are medical devices designed to facilitate vascular access during interventional procedures. They feature a locking mechanism that ensures stability and security during catheter insertion and manipulation. This device is particularly useful in procedures requiring precise catheter placement, such as embolization.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, these sheaths are employed in procedures like embolization, where stable vascular access is crucial. They are suitable for use in hospital settings, particularly in catheterization labs or interventional suites, and are often used in adult patients requiring complex vascular interventions.
Indications for Use
The FDA indications suggest that the device is intended for use in vascular procedures, specifically those involving embolization coils. It is suitable for patients requiring precise and secure catheter placement during such interventions.
Practical Considerations
The sheaths come in various sizes to accommodate different catheter diameters and patient anatomies. They are compatible with standard vascular catheters and require careful insertion technique to ensure proper locking and stability. Clinicians should be familiar with the locking mechanism to maximize device efficacy.
Related Literature
The linked study explored a non-invasive technique for removing encrusted nephrostomy tubes using a vascular introducer sheath. The study demonstrated that this method is safe and effective for managing complicated nephrostomy removals, particularly when traditional methods are challenging. However, the study's limitations include its focus on a specific clinical scenario and lack of large-scale data.
Frequently Asked Questions
What is Inner-Lock Locking Introducer Sheaths used for?
They are used for vascular access in interventional procedures, providing stability and security during catheter insertion.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in vascular procedures, particularly those involving embolization coils.
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.