Ureteral Catheter Connector

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

510(k) Number

K820868 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Al Askari Percutaneous Access Needle Holder

  Class I

  FDA 510(k) K851162 Active Cleared 15 Apr 1985

• Van-Tec Pediatric Suprapubic Catheter Set

  Class II

  FDA 510(k) K870555 Active Cleared 10 Mar 1987

• Ureteral Catheter Connecting Tube

  Class II

  FDA 510(k) K820866 Active Cleared 26 Apr 1982

• Van-Tec Disposable Flexible Endoscope

  Class II

  FDA 510(k) K860771 Active Cleared 23 Apr 1986

• Van-Tec Segura Stone Basket W/Protective Sheath

  Class II

  FDA 510(k) K870696 Active Cleared 30 Mar 1987

• Van-Tec Bladder Evacuator

  Class II

  FDA 510(k) K880099 Active Cleared 2 Mar 1988

See all devices from Van-Tec, Inc. →

• What is the Ureteral Catheter Connector used for?

  The Ureteral Catheter Connector is designed to connect ureteral catheters for use in urological procedures, enabling secure attachment between catheter components during clinical use.

• Is the Ureteral Catheter Connector sterile or non-sterile when supplied?

  The device is supplied non-sterile, meaning it must be cleaned and sterilized by the user prior to each use according to established reprocessing protocols for reusable medical devices.

• Can the Ureteral Catheter Connector be reused, and what does that mean for handling?

  The device is intended for reusable use, allowing multiple applications after proper cleaning, disinfection, and sterilization between uses, in accordance with the manufacturer’s instructions and healthcare facility protocols.

• What regulatory clearance does the Ureteral Catheter Connector have, and when was it granted?

  The device received FDA 510(k) clearance under submission number K820868 on April 26, 1982, confirming its substantial equivalence to a legally marketed predicate device.

• What is the device classification and product code for the Ureteral Catheter Connector?

  The Ureteral Catheter Connector is classified as a Class II medical device with the FDA product code KOD, falling under regulation 876.5130 for urethral and urinary catheters and related devices.