Catheter Introducer for StealthStation System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Catheter Introducer for the Stealthstation System

510(k) Number

K022126 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medtronic Surgical Navigation Technologies →

• What types of surgical procedures is this catheter introducer designed to assist with, and how does it integrate with the StealthStation system?

  This catheter introducer is specifically designed for neurosurgical procedures that require precise catheter placement. It integrates with the StealthStation navigation system by using active LEDs, passive reflective markers, or electromagnetic coils to enable real-time tracking. This ensures accurate positioning of the catheter within the anatomical reference frame, improving procedural guidance during image-guided surgeries.

• Is this catheter introducer meant for reuse, or is it intended for single-use only? How does this affect its use in clinical settings?

  The catheter introducer is intended for single-use only, as explicitly stated in the device description. This design choice reduces the risk of cross-contamination and ensures sterility for each procedure, which is critical in neurosurgical settings where infection control is paramount. Clinicians must follow single-use protocols to maintain safety and compliance.

• What tracking technologies does this device use, and how does it ensure accurate catheter placement during surgery?

  The catheter introducer relies on the StealthStation system’s tracking infrastructure, which supports active LEDs, passive reflective markers, or electromagnetic coils to monitor its position. These technologies enable precise tracking within the anatomical reference frame, allowing surgeons to visualize and confirm catheter placement in real time during image-guided neurosurgical procedures.

• Is this device supplied as a standalone product, or is it part of a larger system? If it’s part of a system, what does that mean for compatibility and use?

  The catheter introducer is supplied as part of the StealthStation system, meaning it is not sold independently. This ensures seamless integration with the navigation system’s tracking and imaging capabilities. Clinicians must use it exclusively with the StealthStation to maintain accuracy and functionality, as the device’s tracking relies on the system’s infrastructure.