# K972957: SA-EF Multi-Lumen Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Vlv Associates, Inc.
- Decided: Sep 29, 1997 after 49 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. The FDA summary names no predicate by number.

## Indications for use
The SA.EF Multi-Lumen Extension Sets are to be used for the conveying of IV Fluids, Medications (drugs), and Nutrients into the intravascular system.

Source page: https://510kreport.com/device/K972957
Methodology: https://510kreport.com/methodology