# K964455: Polyfin with Wings Infusion Sets, Models 306, 307, 333

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Jan 30, 1997 after 85 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
Longest line of descent: 2 generations back to K831445 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961474: Polyfin Infusion Set MMT-106/MMT-107/MMT-133, Medtronic Minimed (1996) Summary page 1.

## Indications for use
The Polyfin with Wings infusion set is intended for use as an infusion administration set for delivery of appropriately labeled fluids or solutions from an external infusion pump or syringe.

Source page: https://510kreport.com/device/K964455
Methodology: https://510kreport.com/methodology