# K061766: Expressway Intermittent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Percutaneous Systems, Incorporated
- Decided: Mar 9, 2007 after 260 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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) SLIP Urology Catheter: named in the summary without a submission number

## Indications for use
The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement

Source page: https://510kreport.com/device/K061766
Methodology: https://510kreport.com/methodology