# K153502: ClariVein IC

- Pathway: 510(k) (Special)
- Applicant: Vascular Insights, LLC
- Decided: Jan 6, 2016 after 30 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: 5 generations back to K904788 (1990). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071468: Clarivein Catheter, Vascular Insights, LLC (2008) Summary page 4.

## Most influential descendants
- K201907: ClariVein IC (2020), 2 descendants of its own
- K250794: InVera Infusion Device (2026), 0 descendants of its own
- K231148: ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (2023), 0 descendants of its own

## Indications for use
The ClariVein IC is indicated for infusion of physician specified agents in the peripheral vasculature.

Source page: https://510kreport.com/device/K153502
Methodology: https://510kreport.com/methodology