XC11 ICE System

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

Full name

XC11 ICE System, USA

510(k) Number

K250955 ↗

FDA Product Code

OBJ

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• What types of procedures is the XC11 ICE System primarily used to guide, and why is real-time imaging important in these settings?

  The XC11 ICE System is designed for intracardiac echocardiography (ICE) imaging, which provides real-time visualization of cardiac structures and blood flow during catheter-based interventions. This is critical in procedures like structural heart interventions (e.g., mitral valve repairs, atrial septal defect closures) or electrophysiology studies, where precise guidance is essential to ensure accuracy, minimize risks, and avoid complications.

• Is the XC11 ICE System intended for single-use or reusable applications, and what maintenance is required?

  The XC11 ICE System is supplied as a reusable device, meaning it is designed for multiple uses after proper sterilization and maintenance. Users must follow the manufacturer’s instructions for cleaning, sterilization, and upkeep to ensure safety, performance, and longevity. This includes adhering to protocols for disinfection and storage to prevent contamination or damage.

• How do I determine which model or size of the XC11 ICE System is appropriate for my patient or procedure?

  The XC11 ICE System comes in multiple configurations, as indicated by the extensive list of registration numbers in the FDA database. While the exact sizing details (e.g., catheter diameter, length, or tip shape) are not provided here, these variations are typically tailored to accommodate different patient anatomies, procedural needs, or access routes (e.g., femoral, jugular). Consulting the manufacturer’s product catalog or technical specifications will help match the correct model to your clinical requirements.

• What regulatory pathway was followed for the FDA clearance of the XC11 ICE System, and how does this affect its use?

  The XC11 ICE System received FDA clearance through a 510(k) Traditional Review process, classified as Substantially Equivalent (SESE) under the Cardiovascular (CV) Advisory Committee. This means the device was determined to be as safe and effective as a legally marketed predicate device (an intravascular ultrasound catheter) and adheres to special controls for its product code (OBJ). Clinicians may rely on this clearance to confirm the device meets FDA standards for intravascular ultrasound applications in intracardiac procedures.

• How should the XC11 ICE System be stored to maintain its performance and sterility between uses?

  Since the XC11 is reusable, proper storage is critical to preserve its functionality and sterility. The manufacturer’s instructions outline specific storage conditions, likely including protection from moisture, extreme temperatures, and physical damage. Typically, this involves storing the device in a clean, dry environment (e.g., a sealed pouch or dedicated storage case) and following any additional guidelines for shelf life or reprocessing cycles to ensure reliability for subsequent procedures.