# K043019: Vascular Solutions Sclero-Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Dec 1, 2004 after 28 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) needle devices: named in the summary without a submission number
- (no number) syringe devices: named in the summary without a submission number

## Indications for use
The Vascular Solutions Sclero-Kit is indicated for delivery of sclerosing agents. Sclerosing agents may be used for treatment of small uncomplicated varicosities of the lower extremities that show simple dilation with competent valves.

Source page: https://510kreport.com/device/K043019
Methodology: https://510kreport.com/methodology