# K071468: Clarivein Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Vascular Insights, LLC
- Decided: Mar 20, 2008 after 296 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904788 (1990). 9 ancestors in all.
4 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)
- K013635: Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length), Bacchus Vascular, Inc. (2002) Summary page 1.
- K882796: Slip-Coat (TM) Catheters, Cook, Inc. (1988) Summary page 1.

## Most influential descendants
- K153502: ClariVein IC (2016), 3 descendants of its own
- 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

## Recalls of this device
- Nov 9, 2017 · Class II · Z-1146-2018: Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into

## Indications for use
The ClariVeinTM Infusion Catheter is intended for the infusion of physician-specified agents in the peripheral vasculature.

Source page: https://510kreport.com/device/K071468
Methodology: https://510kreport.com/methodology