# K043581: Dual Lumen Catheter

- Pathway: 510(k) (Special)
- Applicant: Acmi Corporation
- Decided: Mar 3, 2005 after 65 days
- Product code: EYB (Catheter, Ureteral, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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: 1 generation back to K930483 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930483: Ureteral Catheter, Surgitek (1993) Summary page 1.

## Most influential descendants
- K180182: Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter (2018), 0 descendants of its own

## Recalls of this device
- Jun 25, 2008 · Not classified · Z-2226-2008: Particulate matter in the catheter

## Indications for use
The dual lumen ureteral catheter is designed for percutaneous and transurethral access and is indicated as a conduit for multiple uses including, but not limited to, ureteral dilation, stone displacement, delivery of contrast material/anesthetic agents and guidewire placement.

Source page: https://510kreport.com/device/K043581
Methodology: https://510kreport.com/methodology