TravaCath

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K770493 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Burette Set with Air Control Lever

  Class II

  FDA 510(k) K780970 Active Cleared 27 Jul 1978

• Sterile Water & Saline in Plastic Btl.

  Class II

  FDA 510(k) K800753 Active Cleared 24 Apr 1980

• Solution Administration Sets

  Class II

  FDA 510(k) K860272 Active Cleared 18 Mar 1986

• Arteoial Blood Sampling Kit 2D9014

  Class II

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• Blood-Solution Administration Set, Surg.

  Class I

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• Flo-Gard 8000 Computer Control Infusi

  Class II

  FDA 510(k) K834154 Active Cleared 25 Jan 1984

See all devices from Travenol Laboratories, S.A. →

• What is the TravaCath used for?

  The TravaCath is a urological catheter specifically designed for urinary drainage and management. It facilitates the safe passage of urine from the bladder to an external collection system, helping to prevent urinary retention and associated complications. This makes it suitable for short- to medium-term catheterisation in clinical environments like hospitals, outpatient clinics, and home healthcare.

• Is the TravaCath intended for single-use or reuse?

  The TravaCath is supplied as a single-use, sterile product. This design ensures patient safety by preventing cross-contamination and maintaining sterility for each procedure, which is critical in clinical settings where hygiene is paramount.

• What regulatory pathway was used for the TravaCath’s clearance?

  The TravaCath was cleared through the FDA’s 510(k) pathway as Substantially Equivalent (SESE) under product code KOD. This means it was determined to have the same intended use, technological characteristics, and performance as a legally marketed device that was not subject to premarket approval. The clearance date was March 21, 1977.

• In which clinical settings is the TravaCath typically used?

  The TravaCath is intended for use in clinical settings where urinary drainage is required, including hospitals, outpatient clinics, and home healthcare environments. Its design supports short- to medium-term catheterisation, making it versatile for various patient care scenarios.

• How is the TravaCath classified under FDA regulations?

  The TravaCath falls under FDA regulation 876.5130, which categorizes it as a urological catheter. This classification helps ensure it meets the necessary safety and performance standards for its intended use in urinary drainage procedures.