Silicone Flow-Directed Thermodilution Catheter

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

510(k) Number

K893435 ↗

FDA Product Code

DYG

Device Class

Class II

Regulation

21 CFR Part 870.1240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Embolectomy Catheter(Modified)

  Class II

  FDA 510(k) K881455 Active Cleared 15 Jun 1988

• Cathlab Silicone Arterial Embolectomy Catheter

  Class II

  FDA 510(k) K905139 Active Cleared 25 Feb 1991

• 3F and 4F Irrigation Embolectomy Catheters

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  FDA 510(k) K897184 Active Cleared 14 Mar 1990

• Cathlab Silicone Occlusion Balloon Catheter

  Class II

  FDA 510(k) K910916 Active Cleared 24 Jun 1991

• Cathlab Silicone Biliary Balloon Catheter

  Class II

  FDA 510(k) K910917 Active Cleared 2 Aug 1991

• Miller Percutaneous Angiographic/Scopic Irri. Cath

  Class II

  FDA 510(k) K897051 Active Cleared 16 Mar 1990

See all devices from Cathlab Corp. →

• What is the Silicone Flow-Directed Thermodilution Catheter primarily used for in clinical settings?

  This catheter is designed for thermodilution measurements during cardiovascular procedures, such as cardiac catheterization. Its gas-filled balloon and flow-directed design help achieve precise placement within the vascular system, enabling accurate hemodynamic assessments like cardiac output determination.

• Is the Silicone Flow-Directed Thermodilution Catheter intended for single-use or repeated use?

  The device is explicitly labeled for single-use only in clinical settings. This ensures sterility and safety for each patient procedure, as it is supplied sterile and not intended for reuse.

• How many sizes or reference codes are available for this catheter, and why does this matter?

  Multiple sizes and reference codes are available (listed in the specifications under `openfda: fei_number`), ensuring compatibility with a wide range of patient anatomies and procedural requirements. This flexibility allows clinicians to select the appropriate size for accurate placement and effective hemodynamic measurements.

• What regulatory pathway was used for FDA clearance of this catheter, and what does that mean for buyers?

  The catheter received FDA 510(k) clearance (K893435) under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance is tied to the Cardiovascular (CV) advisory committee and falls under FDA regulation number 870.1240, confirming its compliance with U.S. medical device standards for cardiovascular diagnostics.

• How should the Silicone Flow-Directed Thermodilution Catheter be stored, and why is this important?

  While the data does not specify storage conditions explicitly, the catheter is supplied sterile, so it must be stored in a way that maintains sterility (e.g., sealed packaging, controlled environment) until use. Proper storage prevents contamination and ensures the device remains safe and functional for its intended single-use procedure.