# K960391: Strato/Infusaid Periport Infusion Set 41770,41771

- Pathway: 510(k) (Traditional)
- Applicant: Strato/Infusaid, Inc.
- Decided: Jul 3, 1996 after 156 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 its predicate without a number.
- (no number) Strato/Infusaid LifePort Infusion Set: named in the summary without a submission number
- (no number) Strato/Infusaid Infuse-a-Port Winged Infusion Set: named in the summary without a submission number

## Indications for use
The Strato/Infusaid PeriPort Infusion Set is indicated for the infusion of drugs and fluids into the Strato/Infusaid PeriPort Peripheral Access Device.

Source page: https://510kreport.com/device/K960391
Methodology: https://510kreport.com/methodology