đź“‹ FDA Reference
Inner-Lock Locking Introducer Sheaths
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 ?
510(k)
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.
FDA-Cleared Indications
- Intended to provide vascular access during interventional procedures.
- Intended to facilitate catheter introduction and manipulation during procedures involving embolization coils.
- FDA-cleared as a Class II device under product code DYB through the 510(k) pathway.
Clinical Applications
- Providing vascular access for embolization procedures using coils.
- Maintaining a stable access pathway while embolization catheters are advanced, positioned and manipulated.
- Supporting catheter-based vascular interventions performed in an interventional radiology, vascular surgery or catheterization setting.
Practical Considerations
- Available sizes should be selected to match the intended catheter or embolization device and the access vessel.
- The sheath is inserted through a vascular access site, commonly in the femoral or other peripheral artery or vein, using standard image-guided access techniques.
- The locking mechanism should be engaged and checked according to the manufacturer’s instructions to reduce movement during catheter manipulation.
- Compatibility with the planned catheter, guidewire and embolization device should be confirmed before use.
- MRI safety and conditional-use information depends on the specific model and materials; the product labeling should be reviewed before MRI. General vascular-access contraindications and risks include vessel injury, bleeding, infection, thrombosis and contrast-related complications.
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.
Procedures that use this device
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.