Flow-Directed Balloon Thermodilution

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

510(k) Number

K812761 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Nova Balloon Thermodilution Infusion

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  FDA 510(k) K832287 Active Cleared 19 Oct 1983

• Dual-Thermistor Thermodilution Cath. & Infu. Cath.

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• Heparin Coated Balloon Thermodilu

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• Nova Balloon Thermodilution Catheter

  Class II

  FDA 510(k) K841639 Active Cleared 12 Aug 1984

• Nova Arterial Embolectomy Catheter

  Class II

  FDA 510(k) K853625 Active Cleared 15 Jan 1986

See all devices from Nova Medical Specialties →

• What clinical settings is the Flow-Directed Balloon Thermodilution catheter primarily used in, and why is it important there?

  The Flow-Directed Balloon Thermodilution catheter is designed for use in intensive care units (ICUs) and cardiac catheterization labs, where precise monitoring of cardiac function is critical. Its balloon-tipped design allows for insertion into the pulmonary artery via venous access, enabling real-time measurement of cardiac output and hemodynamic parameters. This makes it essential for assessing circulatory dynamics in patients with complex cardiovascular conditions, such as those in critical care or undergoing cardiac procedures.

• Is this device single-use or reusable, and what does that mean for clinical workflows?

  This device is explicitly supplied as a single-use, sterile catheter. This means each unit is intended for one patient only and must be discarded after use to maintain sterility and prevent cross-contamination. Clinically, this simplifies workflows by eliminating the need for reprocessing, reducing infection risks, and ensuring consistent performance for each patient.

• What types of hemodynamic parameters can this catheter measure, and how does the thermodilution method work?

  The Flow-Directed Balloon Thermodilution catheter measures cardiac output and other hemodynamic parameters by utilizing a balloon-tipped design inserted into the pulmonary artery. The thermodilution method involves injecting a known volume of cold fluid and measuring the temperature change as it passes through the heart. This allows precise assessment of blood flow and cardiac function, providing critical data for managing patients with hemodynamic instability or cardiac issues.

• Can this device be used in environments with MRI equipment, and if not, why?

  No, this device is not compatible for use in MRI environments. The description explicitly states it is intended for non-MRI settings, likely due to the presence of metallic components or conductive materials that could interfere with MRI imaging or pose safety risks in a magnetic field.

• How is the device calibrated, and what does that process entail for clinicians?

  The device requires calibration prior to use, though the specific calibration process isn’t detailed in the data. Typically, for a thermodilution catheter like this, calibration involves verifying the accuracy of temperature sensors and ensuring the balloon’s proper inflation and deflation mechanics. Clinicians would follow manufacturer guidelines to confirm the device’s readiness for insertion and monitoring, ensuring reliable hemodynamic measurements during patient care.