📋 FDA Reference
Schneider Sidekick Monorail Y-Connector
Schneider Intl.
Summary: The Schneider Sidekick Monorail Y-Connector is a medical device used in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to facilitate the placement of stents in venous pathways.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K897082 ↗
Decision Date ?
March 6, 1990
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Schneider Sidekick Monorail Y-Connector was cleared through the FDA 510k pathway on March 6, 1990. Manufactured by Schneider Intl., it is classified as a Class 2 medical device under product code DQY.
What It Is
The Schneider Sidekick Monorail Y-Connector is a specialized device designed to assist in the placement of venous stents. It features a monorail system that allows for precise control and positioning of the stent within the venous system. This device is particularly useful in procedures that require high accuracy and stability, ensuring optimal stent deployment.
FDA-Cleared Indications
- Use as a percutaneous catheter device during vascular procedures, consistent with FDA product code DQY and the applicable labeling.
- Use only according to the indications, anatomy, catheter compatibility, and procedural instructions in the device's FDA-cleared labeling.
Clinical Applications
- Catheter-based access and manipulation during peripheral vascular procedures.
- Use with compatible catheter systems when controlled guidewire or catheter handling is required.
- Use in interventional procedures performed by trained clinicians under appropriate imaging guidance.
Practical Considerations
- Confirm compatibility with the catheter, guidewire, introducer, and other components before use.
- The supplied record does not provide device dimensions, working lengths, or supported catheter and guidewire sizes; consult the original manufacturer labeling.
- Use sterile technique and inspect the connector and packaging for damage before the procedure.
- MRI safety is not established by the information provided. Review the device's current labeling and determine whether the complete setup contains metallic or other MRI-relevant components before scanning.
- Contraindications, warnings, and handling requirements should be taken from the original FDA-cleared labeling; do not infer a venous-stent indication solely from the device name.
Procedures that use this device
Frequently Asked Questions
What is the Schneider Sidekick Monorail Y-Connector used for?
It is used for facilitating the placement of venous stents in procedures addressing venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in their practice.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures, particularly for patients with narrowed or blocked veins.
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.