Cabot Medical Niagra-Trs Thermal Retention System

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

510(k) Number

K940171 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Corson and Nezhat Suction/Irrigation Probes

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See all devices from Cabot Medical Corp. →

• What is the Niagara-TRS Thermal Retention System used for?

  The Niagara-TRS Thermal Retention System is designed specifically for cardiovascular applications to maintain thermal stability during medical procedures. It helps regulate temperature, ensuring optimal conditions for interventions like catheter-based treatments or other procedures where temperature control is critical to patient safety and procedural success.

• Is the Niagara-TRS Thermal Retention System reusable or single-use?

  The Niagara-TRS Thermal Retention System is supplied as a reusable device. This design allows for repeated use in controlled clinical settings, provided it adheres to manufacturer guidelines for cleaning, sterilization, and maintenance to ensure safety and performance consistency across procedures.

• What regulatory approval does the Niagara-TRS Thermal Retention System hold?

  The Niagara-TRS Thermal Retention System holds FDA 510(k) clearance under the reference number K940171. This clearance confirms that the device meets FDA standards for safety and effectiveness as a Class II medical device, specifically for thermal regulation in cardiovascular procedures. It is authorized for use in the United States.

• How is the Niagara-TRS Thermal Retention System supplied, and what are its key features?

  The system is supplied as a reusable device, intended for use in controlled clinical environments. Its primary function is to maintain thermal stability during cardiovascular procedures, ensuring that temperature fluctuations do not compromise patient safety or procedural outcomes. The device is designed to integrate seamlessly into existing workflows while adhering to strict sterility and safety protocols.

• What are the storage and maintenance requirements for the Niagara-TRS Thermal Retention System?

  Since the Niagara-TRS Thermal Retention System is reusable, it must be stored and maintained according to the manufacturer’s instructions to preserve its functionality and sterility. This typically includes regular cleaning, sterilization (using approved methods), and inspection for wear or damage before each use. Proper storage in a clean, dry environment away from direct sunlight or extreme temperatures is also essential to extend the device’s lifespan and ensure reliable performance.