Flow-Directed Thermodilution Catheter

• • Terminated Z-0305-04 FDA Unclassified (pre-2012) ·initiated 19 Nov 2003 ·on shared 510(k) K812800

  Thermodilution catheters have a potential for ruptured lumens within the catheter.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K812800 ↗

FDA Product Code

KRB

Device Class

Class II

Regulation

21 CFR Part 870.1915

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Introducer, Cat. #int-05FR.

  Class II

  FDA 510(k) K771042 Active Cleared 13 Jul 1977

• Transducer Dome DS106

  Class II

  FDA 510(k) K833096 Active Cleared 3 Nov 1983

• Intk-08 8 French Introducer Kit W/Side

  Class II

  FDA 510(k) K812325 Active Cleared 21 Sep 1981

• DNC 162 Vinca-Flo

  Class II

  FDA 510(k) K770048 Active Cleared 14 Jan 1977

• Introducer, Cat. #int-06FR.

  Class II

  FDA 510(k) K771041 Active Cleared 13 Jul 1977

• Tall Floor Stand Tfs-01

  Class II

  FDA 510(k) K831939 Active Cleared 19 Jul 1983

See all devices from Sorensen Research →

• What clinical setting is the Flow-Directed Thermodilution Catheter primarily used in, and how does it work?

  The Flow-Directed Thermodilution Catheter is designed for critical care and cardiovascular monitoring settings. It measures cardiac output by injecting a known volume of cold saline into the venous system and detecting the resulting temperature change in the pulmonary artery. This thermal dilution method provides accurate hemodynamic assessments, helping clinicians evaluate heart function and circulation efficiency.

• Is the Flow-Directed Thermodilution Catheter reusable, or is it intended for single-use only?

  The device is explicitly intended for single-use in clinical environments. This design ensures sterility and reduces the risk of contamination or cross-infection between patients, which is critical for invasive medical devices.

• What types of monitoring systems are compatible with this catheter, and how is it supplied?

  The Flow-Directed Thermodilution Catheter is supplied as a disposable probe and must be used with compatible monitoring systems designed for thermodilution cardiac output measurements. Since it is a standalone probe, it relies on external systems to process the thermal data and calculate cardiac output.

• Are there any specific storage instructions or conditions mentioned for this device?

  The regulatory data does not specify storage conditions for the Flow-Directed Thermodilution Catheter. However, as a sterile, single-use device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use.