# K250794: InVera Infusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Invera Medical
- Decided: Mar 12, 2026 after 363 days
- Product code: KRA (Catheter, Continuous Flush)
- 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: 7 generations back to K904788 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201907: ClariVein IC, Merit Medical Systems, Inc. (2020) Summary page 5.

## Indications for use
InVera Infusion Device is indicated for the infusion of physician-specified agents, including sclerosant, into veins of the peripheral vasculature (e.g., superficial veins, saphenous veins).

Source page: https://510kreport.com/device/K250794
Methodology: https://510kreport.com/methodology