# K941417: Vitaflon Plus/Vasculon

- Pathway: 510(k) (Traditional)
- Applicant: Hogan & Hartson
- Decided: Oct 6, 1994 after 197 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853701 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883415: Vasculon 2 Intravenous Cannula, Ohmeda Medical (1988) Summary page 1.
- K893546: Optically Clear Radiopaque Catheter, Critikon Company, LLC (1989) Summary page 1.
- K853701: Jelco & Cathlon IV Striped IV Catheters-Radiopagul, Critikon Company, LLC (1985) Summary page 1.
- K921845: Insyte Artcath Arterial Catheterization Unit, Becton Dickinson Vascular Access, Inc. (1992) Summary page 1.
- K851293: Implantofix, Burron Medical Products, Inc. (1986) Summary page 1.

## Indications for use
These catheters are for the same intended use and function and are indicated to gain access to the peripheral vein of the blood system for intravenous therapy, blood transfusion and pressure monitoring.

Source page: https://510kreport.com/device/K941417
Methodology: https://510kreport.com/methodology