# K050205: Benephit Bifurcated Infusion Catheter and 5FR. Introducer Sheath

- Pathway: 510(k) (Special)
- Applicant: Flowmedica, Inc.
- Decided: Mar 4, 2005 after 35 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K082163: Flowmedica Benephit Infusion Systems (2008), 0 descendants of its own

## Recalls of this device
- Apr 30, 2010 · Not classified · Z-1734-2010: Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile prod
- Apr 30, 2010 · Not classified · Z-1733-2010: Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile prod

## Indications for use
The FlowMedica Benephit TM A Bifurcated Infusion Catheter is intended for the infusion of physician-specified agents in the peripheral vasculature including but not limited to the renal arteries. The FlowMedica Benephit TM A 5Fr. Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

Source page: https://510kreport.com/device/K050205
Methodology: https://510kreport.com/methodology