# K222185: Stratus Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Intervene, Inc.
- Decided: Apr 13, 2023 after 265 days
- Product code: NPG (Catheter, Infusion, Syringe)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913517 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161402: Bullfrog Micro-Infusion Device, Mercator Medsystems, Inc. (2016) Summary page 4.

## Indications for use
In selective areas of peripheral veins between 7 and 16 mm in diameter, the Stratus Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the vein wall or perivascular area, or intraluminally.

Source page: https://510kreport.com/device/K222185
Methodology: https://510kreport.com/methodology