Polyurethane Thermal Dilution Catheter

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

Full name

Polyurethane Thermal Dilution Cathet

510(k) Number

K841876 ↗

FDA Product Code

DYG

Device Class

Class II

Regulation

21 CFR Part 870.1240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Waters Instruments, Inc. →

• What is the Polyurethane Thermal Dilution Catheter used for?

  This catheter is designed for measuring cardiac output using the thermal dilution technique. It is inserted into the cardiovascular system to provide accurate hemodynamic assessments, particularly in clinical settings where precise cardiac output monitoring is required, such as intensive care or cardiac surgery.

• Is the Polyurethane Thermal Dilution Catheter sterile and single-use?

  Yes, the catheter is supplied as a single-use, sterile device. This ensures patient safety by preventing cross-contamination and maintains accuracy for one-time diagnostic use, adhering to standard medical protocols for sterile, disposable catheters.

• What materials is the catheter made from?

  The catheter is manufactured from polyurethane, a durable and biocompatible material suitable for cardiovascular applications. Polyurethane is chosen for its flexibility, strength, and resistance to degradation during use.

• How is the catheter regulated and approved?

  The Polyurethane Thermal Dilution Catheter is regulated under FDA 510(k) clearance with the classification number K841876. It is classified under regulation number 870.1240 and is intended for use in cardiovascular procedures, adhering to FDA standards for flow-directed catheters.

• What are the key specifications or models associated with this catheter?

  This catheter falls under the product code DYG and is listed under multiple registration numbers in the FDA database, including 1721676 and others. While the exact model variations are not detailed in the provided data, it is categorized as a flow-directed catheter for thermal dilution measurements, ensuring compatibility with standard hemodynamic monitoring systems.