# K020189: Exel Butterfly Scalp Vein Set

- Pathway: 510(k) (Traditional)
- Applicant: Exelint International, Co.
- Decided: Mar 27, 2003 after 433 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
EXEL Scalp Vein (butterfly) set is used for administration of IV solution or infusion of medication to the patient via vascular system.

Source page: https://510kreport.com/device/K020189
Methodology: https://510kreport.com/methodology