# K090918: Nfocus Neuromedical Echo Distal Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Nfocus Neuromedical, Inc.
- Decided: Jul 30, 2009 after 120 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Envoy Guiding Catheter: named in the summary without a submission number
- (no number) Neuron Intracranial Access System: named in the summary without a submission number

## Indications for use
The Nfocus Neuromedical Echo Distal Access Catheter Vessel is indicated for the introduction of interventional and/or diagnostic devices and fluid infusion into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K090918
Methodology: https://510kreport.com/methodology