# K011646: Neuroedge Infusion  Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Neuro Vasx, Inc.
- Decided: Aug 27, 2001 after 90 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: 2 generations back to K903606 (1990). 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)
- K984258: Neurovasx Sub-Microinfusion Catheter, Neuro Vasx, Inc. (1999) Summary page 2.
- K003925: Prowler Infusion Catheters with Pre-Shaped Tips, Cordis Neurovascular, Inc. (2001) Summary page 2.
- K964352: Torque Device, B.Braun Medical, Inc. (1997) Summary page 2.

## Indications for use
The NeuroEdge™ Infusion Catheter is intended for the infusion of various diagnostic, embolic and therapeutic agents into the neurovasculature.

Source page: https://510kreport.com/device/K011646
Methodology: https://510kreport.com/methodology