Vasculon I.V. Cannulae

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

510(k) Number

K850278 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Viggo Secalon T Catheter

  Class II

  FDA 510(k) K850460 Active Cleared 11 Apr 1985

• Viggo Arterial Cannula

  Class II

  FDA 510(k) K850349 Active Cleared 9 Apr 1985

• Viggo Accessories for I.V. Therapy

  Class II

  FDA 510(k) K850769 Active Cleared 29 May 1985

• Viggo Neoflon Infusion Cannula

  Class II

  FDA 510(k) K850276 Active Cleared 12 Apr 1985

• Viggo Connecta 3-Way Infusion Stopcock

  Class II

  FDA 510(k) K850280 Active Cleared 11 Apr 1985

• Viggo I.V. Accessories-Viggo Extension Tubes Etc.

  Class II

  FDA 510(k) K850277 Active Cleared 12 Apr 1985

• What is the Vasculon I.V. Cannulae designed for?

  The Vasculon I.V. Cannulae are intravascular catheters intended for short-term intravenous access (up to 30 days). They are specifically engineered to deliver fluids, medications, or blood products directly into a patient’s vein in general hospital settings. Their design ensures stability and reliability during temporary procedures.

• Are the Vasculon I.V. Cannulae sterile and single-use?

  Yes, the Vasculon I.V. Cannulae are supplied sterile and are intended for single-use only. This ensures patient safety by preventing contamination and cross-infection, which is critical for medical devices used in direct vascular access.

• What storage and handling precautions should be taken?

  The cannulae must be stored and handled according to standard sterile medical device protocols to maintain their integrity before use. This includes keeping them in a sealed, sterile packaging until ready for clinical application, as per best practices for intravenous access devices.

• What regulatory pathway was followed for FDA clearance?

  The Vasculon I.V. Cannulae were cleared through the FDA’s 510(k) process as substantially equivalent to a predicate device. The submission was reviewed by the General Hospital Review Panel in 1985 and classified under product code FOZ, confirming compliance with FDA regulations for short-term intravascular catheters.

• Are there any special considerations for reuse or MRI safety?

  The regulatory data does not specify reusable specifications or MRI safety for the Vasculon I.V. Cannulae, indicating they are intended for single-use only and not designed for MRI environments. Always follow manufacturer guidelines and clinical protocols to ensure safe and effective use.