Triple Lumen Urodynamic Catheter With Radiopaque Markers

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

510(k) Number

K940203 ↗

FDA Product Code

FEN

Device Class

Class II

Regulation

21 CFR Part 876.1620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Life-Tech Intl., Inc. →

• What clinical specialties commonly use the Triple Lumen Urodynamic Catheter With Radiopaque Markers, and why is it beneficial for those fields?

  The Triple Lumen Urodynamic Catheter is primarily used in urology and gastroenterology specialties. It is designed for urodynamic studies, which assess bladder pressure, outflow resistance, and fluid infusion during diagnostic evaluations of lower urinary tract function. The three lumens allow simultaneous measurements, while the radiopaque markers ensure precise catheter placement under fluoroscopy, making it ideal for procedures requiring detailed visualization and accurate pressure monitoring.

• Is this catheter intended for single-use or repeated use in clinical settings, and what does that mean for handling?

  The Triple Lumen Urodynamic Catheter is intended for single-use only. This means it must be discarded after one procedure to maintain sterility and prevent cross-contamination. Proper handling, including sterile packaging and adherence to manufacturer guidelines, is critical to ensure safe and effective use in clinical settings.

• How is the catheter supplied, and what should clinicians check before using it to ensure proper functionality?

  The catheter is supplied sterile in its packaging, ready for immediate use in clinical settings. Clinicians should verify that the radiopaque markers are visible (indicating no damage to the catheter) and that the three lumens are intact and free of obstructions. Additionally, they should confirm the expiration date and ensure the packaging remains unopened and undamaged to maintain sterility.

• What storage conditions are recommended to preserve the catheter’s integrity before use?

  Since the catheter is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the device remains uncontaminated and functional until use. Always follow the manufacturer’s instructions for storage to maintain sterility and performance.

• What regulatory pathway was followed for FDA clearance of this device, and who is the manufacturer?

  The Triple Lumen Urodynamic Catheter received FDA 510(k) clearance (K940203) under the Traditional Review pathway, demonstrating it is substantially equivalent to a legally marketed device. The manufacturer is Life-Tech Intl., Inc., based in Houston, TX, and the device is classified as a Class II medical device under FDA regulation 876.1620 for cystometric and hydraulic catheters.